3i T3 Implant Surgical Manual_CATMT3_EN

7/22/2019 3i T3 Implant Surgical Manual_CATMT3_EN

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Surgical ManualPreservation By Design


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Instructions For Use:

For a detailed explanation of the osteotomy preparation andimplant placement guidelines, refer to the appropriateSurgical Manual(s).

Description:

BIOMET 3i Dental Implants are manufactured frombiocompatible titanium or titanium alloy. BIOMET 3i DentalImplants include various surface treatments. For specific productdescriptions refer to individual product labels.

Indications For Use:

BIOMET 3i Dental Implants are intended for surgical placementin the upper or lower jaw to provide a means for prostheticattachment in single tooth restorations and in partially or fullyedentulous spans with multiple single teeth, or as a terminal orintermediary abutment for fixed or removable bridgework, and

to retain overdentures.

Contraindications:

Placement of dental implants may be precluded by both patientconditions that are contraindications for surgery as well ashypersensitivity to commercially pure titanium or titanium alloy(including vanadium, aluminum, and calcium phosphate).

BIOMET 3i Dental Implants should not be placed in patientswhere the remaining jaw bone is too diminished to provideadequate implant stability.

Warnings:

Excessive bone loss or breakage of a dental implant may occur

when an implant is loaded beyond i ts functional capabi lity.Physiological and anatomical conditions may affect theperformance of dental implants.

Mishandling of small components inside the patients mouthcarries a risk of aspiration and/or swallowing.

Forcing the implant into the osteotomy deeper than the depthestablished by the drills can result in damage to implant, driver,or osteotomy.

For short implants, clinicians should closely monitor patients forany of the following conditions: peri-implant bone loss, changes

to the implants response to percussion or radiographic changes

in bone to implant contact along the implants length. If theimplant shows mobility or greater than 50% bone loss, theimplant should be evaluated for possible removal. If a clinicianchooses a short implant, then the clinician should consider a

two-stage surgical approach, splinting a short implant to anadditional implant, and placement of the widest possible fixture.In addition, the clinician should allow longer periods forosseointegration and avoid immediate loading.

Reuse of BIOMET 3i Products that are labeled for single-use mayresult in product contamination, patient infection and/or failure of

the device to perform as intended.

MRI Statement:

BIOMET 3i Dental Implants have not been evaluated for safetyand compatibility in the Magnetic Resonance Imaging (MRI)environment. BIOMET 3i Dental Implants have not been tested

for heating or migrat ion in the Magnetic Resonance Imagingenvironment.

Precautions:

These devices are only to be used by trained professionals.The surgical and restorative techniques required to properlyutilize these devices are highly specialized and complexprocedures. Improper technique can lead to implant failure,loss of supporting bone, restoration fracture, screw looseningand aspiration. When the clinician has determined adequateprimary stability is achieved, immediate functional loading canbe considered.

The following should be taken into consideration when placingdental implants: bone quality, oral hygiene, and medicalconditions such as blood disorders or uncontrolled hormonalconditions. The healing period varies depending on the quality of

the bone at the implantation site, the tissue response to theimplanted device and the surgeons evaluation of the patientsbone density at the time of the surgical procedure. Properocclusion should be evaluated on the implant restoration toavoid excessive force during the healing period on the implant.

It is recommended that implants less than 4mm diameter NOTbe placed in the posterior regions.

Sterility:

All dental implants are suppl ied sterile and are labeled STERILE.All products sold sterile are for single-use before the expirationdate printed on the product label. Do not use sterile products if

the packaging has been damaged or previously opened.Do not re-sterilize.

Storage and Handling:

Devices should be stored at room temperature. Refer toindividual product labels and the Surgical Manual for specialstorage or handling conditions.

Potential Adverse Events:

Potential adverse events associated with the use of dentalimplants may include: failure to integrate, loss of integration,

dehiscence requiring bone grafting, perforation of the maxillarysinus, inferior border, lingual plate, labial plate, inferior alveolarcanal or gingiva, infection as reported by abscess, fistula,suppuration, inflammation, or radiolucency, persistent pain,numbness, paresthesia, hyperplasia, excessive bone lossrequiring intervention, implant breakage or fracture, systemicinfection, nerve injury, and aspiration.

Caution:

U.S. Federal Law restricts this device to sale by or on the orderof a licensed dentist or physician.

Important Product Information

This document applies to Dental Implants.


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Table Of Contents

Introduction And Treatment Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1

Preoperative Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2

Top-Down Treatment Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4

Surgical Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

Cleaning And Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

Bone Density . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

3i T3Tapered Implants

Why Tapered Implants Are Different . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

Quad Shaping Drills (QSDs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

Twist Drill Depth Marking System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-14

Implant Depth/Direction Indicator (NTDI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15Implant Bone Taps And Bone Tap Kit (NTAPK) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

Implant Surgical Tray (QNTSK) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

Quick Reference Subcrestal Surgical Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18-19

Subcrestal Surgical Protocol

3i T3 Tapered 3.25mm(D) Implants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20-22

3i T3 Tapered 4mm(D) x 3.4mm(P) & 3i T3 Tapered 4mm(D) Implants . . . . . . . . . . .23-25

3i T3 Tapered 5mm(D) x 4.1mm(P) & 3i T3 Tapered 5mm(D) Implants . . . . . . . . . . .26-28

3i T3 Tapered 6mm(D) x 5mm(P) & 3i T3 Tapered 6mm(D) Implants . . . . . . . . . . . .29-32

Subcrestal Implant Placement Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33-35

3i T3 Parallel Walled ImplantsTwist Drill Depth Marking System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37-41

Quick Reference Subcrestal Surgical Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42-43

Subcrestal Surgical Protocol

3i T3 Parallel Walled 3.25mm(D) Implants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44-45

3i T3 Parallel Walled 4mm(D) x 3.4mm(P) & 3i T3 Parallel Walled 4mm(D) Implants . .46-47

3i T3 Parallel Walled 5mm(D) x 4.1mm(P) & 3i T3 Parallel Walled 5mm(D) Implants . .48-49

3i T3 Parallel Walled 6mm(D) x 5mm(P) & 3i T3 Parallel Walled 6mm(D) Implants . . .50-52

Subcrestal Implant Placement Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53-55

3i T3 Tapered & Parallel Walled ImplantsSurgical Indexing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56-57

Single Stage Treatment Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58

Mountless Delivery Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59

Implant Placement In Dense Bone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60-61

Bone Profiling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62


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1

Introduction And Treatment Planning

These instructions were designed to serve as a

reference guide for dental practitioners

utilizing Implants and Surgical

Instruments.

The design of BIOMET 3i Implants and SurgicalInstruments enable the practitioner to place implantsin edentulous or partially edentulous mandibles ormaxillae in order to support fixed and removablebridgework or single tooth crowns and overdentures.

General Information:The success of any dental implant systemdepends upon proper use of the componentsand instrumentation. This manual is not intended

for use as a substitute for professional training

and experience.

Treatment Planning:Patient Evaluation And SelectionSeveral important factors must be considered whenevaluating a patient prior to implant surgery. Thepresurgical evaluation must include a cautious anddetailed assessment of the patients general health,current medical status, medical history, oral hygiene,motivation and expectations. Factors such as heavy

tobacco use, masticatory function and alcoholconsumption should also be considered. In addition,

the clinician should determine if the case presents an

acceptable anatomical basis conducive to implantplacement. An extensive intraoral examination shouldbe undertaken to evaluate the oral cavity for anypotential bone or soft-tissue pathology. The examinershould also determine the periodontal status of the

remaining teeth, the health of the soft tissue and thepresence of occlusal abnormalities such as bruxism orcrossbite. The presence of other conditions that couldadversely affect any existing natural dentition or

healthy soft tissue surrounding the implant should alsobe evaluated.

Diseases of the mucous membrane and connectivetissues, pathologic bone disease and severemalocclusion could affect the determination of

whether a patient is a suitable implant candidate.

The use of anticoagulants and the existence ofmetabolic diseases, such as diabetes, allergies, chronicrenal or cardiac disease and blood dyscrasia couldsignificantly influence the patients ability tosuccessfully undergo implant procedures.

If the patients medical history reveals an existingcondition or signals a potential problem that maycompromise treatment and/or the patients well-being, consultation with a physician is recommended.

BIOMET 3i T3 Platform-Switched Implants areintended to be used for surgeries where the clinician

would like to medialize (platform-switch) theimplant/abutment junction.


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2

Preoperative Planning

Preoperative Planning:Proper treatment planning, as well as the selection of theproper implant length and diameter, are crucial to thelong-term success of the implant and restoration.

Before an implant can be selected, the anatomicalfoundat ion avai lable to receive the implant must becarefully assessed. Several steps should be taken tocomplete the evaluation:

1. Clinical examination of the oral cavity can provideimportant information about the health of the soft

tissue at the proposed implant site. Tissue tone andthe state of the superf icial tissues should be evaluated.In addition, the patient should demonstrate anadequate dimension of attached gingiva or keratinized

tissue at the site selected for implantation. In part iallyedentulous cases, the periodontal status of theremaining dentition should be assessed andinteraction between the implant restoration and theadjacent natural dentition should be considered.

2. The bony foundation and ridge need to be clinicallyanalyzed to ensure the presence of properdimensions and the amount of bone for implantplacement. At least one millimeter of bone should bepresent at the buccal and lingual aspects of the implant

following placement. During the planning stage, it isuseful to measure the existing bone foundation.

CT Scans:Computed tomography (CT) scans help surgeons viewparts of the body with three-dimensional images.Image-guided surgical planning allows surgeons to seeanatomical landmarks such as nerves, sinus cavities andbony structures in order to plan for the placement ofdental implants and prostheses.

Through the use of CT scans, clinicians are able tomore precisely measure the locations of anatomicalstructures, dimensions of the underlying bone andascertain bone densities in order to plan and treatclinically demanding cases.

Radiographic Marking Balls (RMB30)The vertical height of the bone can be determinedradiographically. Accurate measurement of the verticaldimension on the radiograph facilitates the selection of

the appropriate implant length. This helps to avoidimplant placement into the maxillary sinus, the floor of

the nose or the mandibular canal and preventsperforation of the inferior aspect of the mandible.Measurements can be made directly on the panoramicradiograph using a millimeter ruler. Corrections shouldbe made for the degree of enlargement produced by theparticular radiographic equipment.

Radiographic marking balls of a known dimension can beembedded in a plastic template prior to radiographicexamination. Once the radiograph is taken and the metalmarking balls are visible on the image, measurementscan be taken to determine the amount of bone available

for implant placement.

To calculate the distortion factor, a simple

formula can be utilized: (5 A) x B = the

amount of actual bone available.

Formula Key = Radiographic marking ball = 5mm in diameter. A = Size of marking ball image on radiograph. B = Length in millimeters on the radiograph of

available bone between the crest of the ridgeand the inferior alveolar canal.

Example:A = 6.5mmB = 14mm

Therefore: (56.5) x 14 = 10.76mm actual bone available

NOTE: A 2mm margin of safety, from the apical end of the implant

to the adjacent vital structure, should be considered.

Inferior Alveolar

Nerve Canal

Marking Ball Image

(6.5mm on this radiograph)

A

B


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3

Top-Down Treatment Planning

In its simplest form, top-down treatment planning refersto a guideline whereby the desired restorative result isconsidered first, leading to consideration of theappropriate prosthetic platform and subsequent implant

selection based on bony anatomy and the size of themissing tooth.

A top-down treatment planning methodology willprovide maximum biomechanical stability and allow forsoft-tissue flaring by utilizing an implant with a prostheticplatform slightly smaller in diameter than the emergencediameter of the tooth being replaced. The wideselection of Implants allows clinicians tomatch the size of the prosthetic platform to therestoration it will eventually support, while allowing fordifferent bone volumes and anatomical features at the

implant site. Implant and healing abutment selections arebased upon the relationship of several key measurements:

The emerging dimension of the crown in relation to

the diameter of the prosthetic platform of the implant

The height and diameter of the intended restorationat the tissue exit point

The bone volume at the implant site in relation to thediameter of the implant body

The Emergence Profile (EP) Healing Abutment Systemconsists of healing abutments of various diameters andheights for shaping the soft tissue to replicate thegeometry and gingival contours of natural dentition.

Anterior 4 4 4 4 4 4 4

Posterior 4 4 4 4 4 4

Implant Indications: Include both straight and pre-angled restorative components.

NOTE: It is recommended that implants less than 4mm diameter not be placed in the posterior regions.

4mm(D) 5mm(D) 6mm(D)

3.25mm(D) 4mm(D) 5mm(D) 6mm(D) X 3.4mm(P) X 4.1mm(P) X 5mm(P)


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Top-Down Treatment Planning (Contd)

7.5

3.54

5.5 5

8 9 5 5.55

8 58 5

6mm 6mm 4mm 5mm

6mm 3.25mm4mm 5mm6mm

3.25mm 5mm4mm

3.25mm4mm

7.5

3.54

5.5 5

8 9 5 5.55

8 58 5

6mm 6mm 4mm 5mm

6mm 3.25mm4mm 5mm6mm

3.25mm 5mm4mm

3.25mm4mm

3i T3 Parallel WalledImplants

3i T3TaperedImplants

BNST6xx BOPT65xx BOST4xx BNST4xx BOST5xx BOST32xx BNPT54xx

BNSS6xx BOPS65xx BOSS4xx BNPS43xx BOSS5xx BOSS32xx BNPS54xx

BNPT65xx BOST6xx BOPT43xx BNST5xx BNPT43xx BNST32xx BOST32xx

BNPS65xx BOSS6xx BOPS43xx BNSS5xx BNPS43xx BNSS32xx BOSS32xx

Crown

Diameter

Crown

Diameter

ImplantDiameter

ImplantDiameter


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5

Surgical Precautions

Clinical Considerations:True bone contours can only be evaluated after tissue

flaps have been reflected at the time of surgery or withpreoperative high quality CT scans. Even if bone

dimensions are painstakingly measured prior to surgery,the doctor and patient must accept the possibility thatinadequate bone anatomy might be discovered duringsurgery and preclude implant placement.

During the presurgical planning phase, it i s important todetermine the interocclusal clearance - the actual spaceavailable between the alveolar crest and the opposingdentition - to confirm that the available space willaccommodate the proposed abutment and thedefinitive crown restoration. The height required by theabutment may vary with the type of abutment;

therefore, the surgeon and restorat ive dentist should

carefully evaluate the abutment size. The definitiveprosthesis should be conceptually designed prior to theplacement of the implant.

Diagnostic casts can be used preoperatively to evaluatethe residual ridge and to determine the position andangulation of all implants. These casts allow the clinician

to evaluate the opposing dent ition and its effect on theimplant position. A surgical guide stent, which is critical

for determining the precise position and angulat ion ofthe implant, can be constructed on the diagnostic cast.

Several software companies offer planning softwarethat allow clinic ians to plan implant placement three-dimensionally in conjunction with CT scans. From planscreated in these software packages, surgical guides canbe made to aid in the pre-angulation and placementof implants.

To prevent damage to the bone tissue and to preventcompromising osseointegration by the bone overheatingduring high speed drilling, copious irrigation with sterile

water or sal ine solut ion is mandatory during alldrilling procedures.

Bone surgery utilizes a high-torque electric drilling unitthat can be operated in forward and reverse modes atspeeds ranging from 0 to 2000rpm, depending on thesurgical requirements. Sharp instruments of the highestquality should be utilized during implant site preparation

to reduce possible overheating and trauma to the bone.Minimizing trauma enhances the potential for successfulosseointegration.

The time elapsed between surgical placement of the

implant and definitive abutment placement can vary orbe modified, depending on the quality of the bone at theimplantation site, bony response to the implant surfaceand other implanted materials and the surgeonsassessment of the patients bone density at the time of

the surgical procedure. Extreme care must be taken toavoid excessive force being applied to the implant during

this heal ing period.


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Cleaning And Sterilization

Single use drills/burs are supplied sterile and shouldbe properly disposed of after each procedure.Reusable drills/burs and instrumentation are suppliednonsterile and must be sterilized prior to use.

Nonsterile items must be removed from thepackaging before sterilization.

Multiple sterilizations may affect the flow of fluidthrough internally irrigated drills . The dril ls should beinspected following each sterilization cycle todetermine if fluid flows through the irrigation ports.

Although the surgical dril ls are constructed of stainlesssteel, these should be adequately dried prior topackaging for sterilization and again after thesterilization cycle. Reusable drills are recommended tobe replaced after15 osteotomy preparations, subject

to the information below.

The end of life for surgical instruments is normallydetermined by wear and damage. Surgical instrumentsand instrument cases are susceptible to damage for a

variety of reasons including prolonged use, misuse,rough or improper handling. Care must be taken toavoid compromising the intended performance of

the instrument.

Visually inspect each instrument before and after eachuse for damage and/or wear.

To extend the useful life of Instruments,certain procedures should always be followed:

Cleaning:1. After use, place drills into a beaker of plain water,

mild soap or specialized cleaning solution.2. Rinse with tap water for a minimum of two

minutes while brushing with a soft bristled brushto remove visible debris. Clean the interior lumenwith a thin wire to remove any remaining debris.

3. Place instruments in an ultrasonic bath containingenzymatic detergent for five minutes.* Scrub theinstruments again with a soft bristled brush and

ream the interior lumen to remove any remainingdebris.4. Rinse and flush the instruments for one minute

using tap water.5. Inspect visually for any remaining bone fragments

or debris and scrub as necessary.

Sterilization:6. Remove the bur block from the surgical tray.

Scrub the surgical tray and block with a soft bristlebrush and mild soap. Rinse thoroughly.

7. Place the components into the surgical tray andpour ethyl alcohol (do not use rubbing alcohol)over the burs and tray to remove soap residueand minerals from the water. This step isimportant to help prevent corrosion and spotting.Let the components dry before wrapping.

8. Wrap the surgical tray in paper or autoclave-approved bags twice to prevent a tear of theouter packaging from contaminating sterileinstruments.

9. Steam gravity sterilization method Minimum oftwenty minutes at a temperature of 270 275F(132 135C).**

Pre-vacuum sterilization method Minimum offour minutes ( four pulses) at a temperature of270 275F (132 135C).**

10. Dry for 30 minutes. Drying times may varyaccording to load size.

NOTES:

1. Multiple sterilizations may affect the flow of fluid

through internally irrigated burs. After each use, ream

the burs individually with wire to remove any bone

fragments or debris that will prevent the flow of water.

This is done prior to the sterilization cycle.

2. Do not remove drills, instrumentation or the surgical

tray from the autoclave until the dry cycle iscomplete. Very Important!

3. These guidelines DO NOT apply to the cleaning and

sterilization of your powered instrumentation. Please

follow your powered instrumentation manufacturers

instructions.

Please refer to P-IFSCSS for complete instructions onthe steril ization and care of stainless steel.

*ENZOL enzymatic detergent was used to validate this process, per the

manufacturers dilution recommendation.

**Post sterilization devices should be thoroughly dried to mitigate the risk

of stainless steel corrosion (30 minutes is typical).


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Bone Density

The protocols detailed in this Surgical Manual havebeen developed to include more specific informationabout drill selection when working in various bonedensities. However, the clinician is responsible for

assessing the bone density of the anatomy whendetermining the appropriate protocol.

The various bone densities can be typicallycharacterized by the following:

Dense (Type I) A thick cortical layer and a veryhigh density trabecular core

Medium (Type II & III) A cortical layer ofmoderate thickness with a reasonably dense

trabecular core

Soft (Type IV) A thin cortical layer and a lowdensity trabecular core

Dense

(Type I)

Medium

(Type II)

Medium

(Type III)

Soft

(Type IV)


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8

3i T3

Platform-Switched Collar

3i T3

Standard Collar

3i T3 with DCD*


3i T3 with DCD*

Standard Collar

*Discrete Crystalline Deposition (DCD) is a process

by which the implant surface is treated with a nano-scale

deposition of biocompatible calcium phosphate crystals.

Tapered Implants


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Why Tapered Implants Are Different3i T3TM Tapered Implants

Due to the geometrical differences that exist between atapered and a paral lel wal led implant, there are severalimportant technique adjustments thatare required.

In all tapered implant placement procedures,the surgeonshould determine the appropriate vertical position of

the implant (supracrestal, crestal or subcrestal) at the

time of osteotomy preparation. The surgeon shouldprepare the tapered osteotomy so that when the implantis fully seated, the implant seating surface is at the desiredposition. The Tapered Implant Depth/Direction Indicator(NTDI) was designed to simulate the tapered implantposition prior to placement.

After preparation of the osteotomy with the final shapingdrill, flush the osteotomy with sterile water or salinesolution and suction out any remaining debris. Select thecorresponding NTDI and place the tapered end into theosteotomy. Check the platform position (crestal orsubcrestal) of the NTDI in relation to the adjacent bone.This position locates where the platform of the taperedimplant will be positioned when properly placed. If duringplacement with the drill unit, the tapered implant platformis higher in relation to the bone than was demonstrated

with the NTDI platform, the clinician should considerusing a hand ratchet to complete the implant placement so

that the tapered portion of the implant body conforms

correctly with the tapered portion of the osteotomy(Figure 1. Proper Subcrestal Placement).

Over Preparingthe osteotomy depth and then placingthe implant at a crestal level may result in a conical spacearound the apical and coronal aspects of the taperedimplant minimizing thread engagement (Figure 2. OverPrepared Subcrestal Placement). This placement positionmay result in decreased implant to osteotomy contact,

with contact occurring only along the parallel coronalportion of the implant, resulting in decreased stability of

the implant.

Under Preparingthe osteotomy depth and then placingthe implant more apical relative to the prepared depthmay result in the implant stopping short of the desiredplacement level. The implant may then spin and loseprimary stability (Figure 3. Under PreparedSubcrestal Placement).

Figure 2

Over Prepared Subcrestal Placement Of 11.5mm Implant

Figure 1

Proper Subcrestal Placement Of 11.5mm Implant

15

13

11.510

8.5

7

15

13

11.5

10

8.5

7

Figure 3Under Prepared Subcrestal Placement Of 11.5mm Implant

15

13

11.5

10

8.5

7


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10

Depth landmarks on the QSD versus corresponding depth landmarks

on the NTDI and depth marks on the ACT Drill for an 11.5mm length

tapered implant.

*{

QSD NTDI

Supracrestal

CrestalSubcrestal

Parallel

Walled

Cutting

Flutes

Tapered

Cutting

Flutes

Apical End

Cutting

*Gingival Depth Marks - These depth marks are not used in the

surgical procedures covered in this manual.

ACT

The Quad Shaping Drills (QSDs) are used to preparethe osteotomy for placement ofTapered Implants.

The BIOMET 3i Depth Measurement System includesdrill depth marks on the ACT Twist Drill thatcorrespond to the placement of the implant via a well-established procedure. The BIOMET 3i protocol

follows the principles of protecting the implant frompremature loading by placing the implant subcrestally.

The Quad Shaping Drills have been designed withgeometrical depth landmarks to assess proper depthrather than laser etched markings. The clinician shouldbecome familiar with these depth landmarks to prevent

over or under preparation of the osteotomy site.

Shaping Drill Speed:QSDs should operate between 1200 1500rpm.

QSDs cut efficiently; reducing the downward forcewill al low the drill to cut without detectable chatter.

Shaping Drill Technique: For either crestal or subcrestal implant p lacement,

drill to the top of either the crestal or subcrestaldepth landmarks on the QSD (full depth - seeillustration to the right).

Do not pump the shaping drill as you might do witha twist drill when creating the osteotomy as it maydistort the dimensions of the osteotomy. Theshaping drill should be advanced once to full depth,

then be removed without any pumping action. Once the shaping drill has reached the desired

depth, pull it out of the site without running the drill.If the drill does not pull out easily, tap the foot pedal

while pulling the drill out. In addition to preservingthe integrity of the osteotomy site, this techniquemaximizes autogenous bone recovery from theshaping drill flutes.

When placing a tapered implant in soft (Type IV)

bone, the surgeon should consider undersizing theosteotomy.The final drill diameter should match

the implant diameter, but be l imited to 8.5mm inlength. This will create an osteotomy of properdimension in the dense cortical bone to receive theimplant, but will slightly undersize the osteotomy in

the cancellous region.

It is required that the clinician tap the

osteotomy when placing a Tapered Implant in

Dense (Type I) Bone.

NOTE: During preparation of the osteotomy, the QuadShaping Drill should advance into the osteotomy using lightpressure. The need to push heavily on the shaping drill mayindicate the need to replace the shaping drill, the need to

tap or that the previous drill depth was inadequate.

Quad Shaping Drills (QSDs)3i T3TM Tapered Implants


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11

Twist Drill Depth Marking System3i T3TM Tapered Implants

ITD Reusable Drills

Internal irrigation lumen All thin lines

Types Of Twist Drills

DT & DTN Disposable Drills

Without internal irrigation lumen Bands DTN disposable drills do not

have a hub

ACT Twist Drill Marks

8.5mm

7mm

Drill Tip

10mm

11.5mm

13mm

15mm

Max 1.3mm

The length of the drill tip is notincluded in the depth markmeasurement. The drill tip lengthshould be considered whenpreparing the osteotomy.

The length of the drill tip varieswith the diameter of the drill .

The center of the drills single line

depth marks and the beginning orend of the broad band indicatesubcrestal placement for thecorresponding length implant.

Drill Tip Dimensions

ACT Reusable Drills

Without internal irrigation lumen Alternating lines and bands No hub

Drill Diameter

ITD/DTN/DT

Drill Tip Length

ACT

Drill Tip Length

2mm 0.6mm 0.6mm

2.3mm 0.7mm N/A 2.75mm 0.8mm 0.9mm

3mm 0.9mm 0.9mm

3.15mm 1mm 1mm

3.25mm 1mm 1mm

3.85mm N/A 1.2mm

4.25mm 0.4mm 1.3mm

4.85mm N/A 1.3mm

5.25mm 0.5mm 1.2mm

A 2mm Twist Dril l is used to prepare the osteotomy forthe sequent ial Quad Shaping Drills (QSDs) in the tapered

surgical protocols.

Pages 12-14 outline the guidelines for understanding thedepth markings on the Twist Drill System.


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12

Twist Drill Depth Marking System (Contd)3i T3TM Tapered Implants

The Depth Marks measurement system

provides a mark on the drill that corresponds to theplacement of the implant via well-establishedprocedures. The original BIOMET 3i protocol follows

the principles of protecting the implant from prematureloading by placing the implant subcrestally.

Drilling DepthThe drilling depth with the Twist Drill will vary dependingon the type of placement related to the bone crest.

The depth marks are specific for subcrestal implantplacement only. There are no specific depth marks on

the drills for crestal or supracrestal placement.

The drill depth marks do not indicate implant lengths.Rather, the drill depth marks represent the length of theimplant with a standard 1mm cover screw in place. As aresult, to place an implant and cover screw subcrestallyrequires drilling to the middle of the single line depthmark or the beginning or end of the broad band depthmark on ACT Drills. For crestal placement, drillhalfway before the corresponding depth mark for theimplant length. For supracrestal placement, the drilldepth mark should remain above the bone by 1mm for

the cover screw plus the implant collar height. Pleaserefer to the diagram at the bottom of page 13 for more

information on supracrestal placement.

Implants are packaged with a 0.4mm tall cover screw.However, the protocols for these implants do not differ

from the protocols for BIOMET 3i Implants packagedwith a 1mm tall cover screw.

Drill TipMax 1.3mm

2mm

Twist Dr ill

Depth Gauge Implant With A

1mm Cover Screw

SubcrestalCrestalSupracrestal

Standard Subcrestal Protocol -

1mm Cover Screw

Drilling Depth Comparison

11.5mm(L) 3i T3 Implant

L = Length


16/67

13

Subcrestal Placement

The implant platform will be 1mm (or more) below the bone crest.

Mostly used in the anterior region for aesthetics

8.5mm

7mm

1mm

Subcrestal

10mm

Bone CrestFor subcrestal implant placement, drill to

the dril l depth mark that corresponds to

the labeled implant length.

11.5mm

Drill TipMax 1.3mm


Labeled vs. Actual Lengths

Drill TipMax 1.3mm

The center of the drillssingle line depth marks and

the beginning or end of thebroad band indicate thelength of the implant with astandard 1mm cover screwin place.

The actual implant lengths from thetop of the implant collar (platform)to the tip of the implant are shorterby 0.4mm than the labeled length.

The landmarks (grooves) onthe Certain Implant DriverTip act as references duringimplant placement.

15mm

LabeledLengths

Actual Implant Lengths With

Full Cover Screw ON

15mm

13mm

11.5mm

10mm

8.5mm

7mm

13mm

11.5mm

10mm

8.5mm

7mm

Subcrestal

Crestal

OptionalCoverScrew

SuppliedCoverScrew



L = Length


17/67

14


Crestal Placement

The implant platform will be at the bone crest.

For crestal implant placement, stopdrilling 1mm beforethe drill depth mark

that corresponds to the labeled implantlength (1mm equals the traditional coverscrew height).

Supracrestal Placement

The implant collar will be above the bone crest.

For supracrestal implant placement, stopdrilling 2.25mm before the drill depthmark that corresponds to the labeledimplant length (2.25mm equals the 1mm

traditional cover screw height plus the1.25mm implant collar height).

NOTE: A Countersink Drill is not needed

for supracrestal implant placement.

Drill Tip

Max 1.3mm

Drill TipMax 1.3mm

8.5mm

7mm

1mm

Crestal

10mmBone Crest

11.5mm

8.5mm

7mm

1.25mmCollarHeight

Supracrestal

10mm Bone Crest

11.5mm



L = Length


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15

The Tapered Implant Depth/Direction Indicator is used to simulatethe implant platform position prior to placing the implant.

Step 1When using the NTDI and after preparation of the osteotomy withthe final shaping dri ll, flush the osteotomy with ster ile saline solut ionand suction out any remaining debris (Figure 1). This will ensure that

the osteotomy is clear of debris that could prevent the NTDI fromfully seating.

Step 2Verify the NTDI platform position in reference to the crest of thebone. This also verifies the depth of the osteotomy that has beencreated. The NTDI platform should be at the level you desire the

implant platform to attain. If the NTDI platform is too high versus thedesired position, then re-drilling to the appropriate depth is required.If the NTDI platform is too deep versus the desired position, thisindicates some degree of osteotomy over preparation has takenplace. To ensure proper engagement of the implant, it must be seated

to the depth demonstrated by the NTDI. A longer implant can beconsidered. The clinician may consider verifying the position of theNTDI with a radiograph (Figure 2).

Step 3When placing the implant, the implant platform should reach thesame position that the NTDI platform previously attained. If theimplant platform is positioned higher in relation to the crest of the

bone than the platform of the NTDI previously demonstrated, or ifthe surgical motor stalls prior to ful l placement of the implant due toinsufficient torque, then hand ratcheting is recommended to achieve

the proper final implant seating position (Figure 3).

These guidelines are designed to help ensure good bone-to-implantcontact and primary stability of the implant.

Figure 1

Figure 2

Figure 3

Implant Depth/Direction Indicator (NTDI)3i T3TM Tapered Implants


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16

Implant Bone Taps And Bone Tap Kit (NTAPK)3i T3TM Tapered Implants

Dense Bone Taps

When placing a tapered implant in Dense (Type I)Bone, tapping the osteotomy prior to implant

placement is required (Figure 1).

Dense Bone Taps are available to fully thread the entireosteotomy. These Dense Bone Taps are both length anddiameter specific to correspond to each tapered implant(Figure 2).

NOTE: Dense Bone Taps shown on this page have replaced

the Standard Tapered Bone Taps.

Tapered Implant Tap Kit (NTAPK)For Use With Tapered Implants In Dense BoneWhen placing a tapered implant, the need to tap theosteotomy may arise, especially in dense bone. The DenseBone Tap Kit has a specific tap that matches each taperedimplant, which then facilitates site specific preparation to aid in

final implant placement. Fully seat the tap to the leveldemonstrated by the NTDI.

NOTE: It is not uncommon for the drill unit to stall before

the tap is completely seated. Final seating of the Dense Bone

Tap may require the use of the Ratchet Extension and the

Ratchet Wrench.

4mm x 8.5mm

Osteotomy

4mm x 13mm

Osteotomy

4mm x 11.5mm

Osteotomy

Figure 1

Figure 2

Tapered Implant Tap Kit (NTAPK)


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17

Coordinating The Use Of The Surgical Tray

With The Surgical Manual Illustrations:

The Surgical Tray (QNTSK) for tapered implantsis numbered to indicate the appropriate steps of

the implant placement protocol. The followingillustrated implant placement protocol uses the

same sequence.

Close-up view of the Surgical Tray illustrating numbering sequence.

Implant Surgical Tray (QNTSK)3i T3TM Tapered Implants


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18

See page 23 for detailed instructions.


Tapered 3.25mm(D) Implants

Tapered 4mm(D) X 3.4mm(P) & Tapered 4mm(D) Implants

2mm

Twist Drill

3.25mm

Depth/

Direction

Indicator

NTDI3211Cover Screw

IMCSF34

3.25mm

Quad

Shaping Drill

QSD3211

Required

Step ForDense Bone

3.25mm

Dense Bone Tap

NTAP3211

2mm

Twist Dr ill

4mm

Quad

Shaping Drill

QSD411

4mm

Depth/

Direction

Indicator

NTDI411

Cover Screw

IMCSF34

Cover Screw

ICSF41

3.25mmQuad

Shaping Drill

QSD3211

4mm

QuadShaping Drill

QSD485

(Final Drill

For Soft

Bone)

3.25mm(D) X 11.5mm(L)

4mm(D) X 4.1mm(C)

X

3.4mm(P) X 11.5mm(L)

4mm(D)

X

11.5mm(L)

ACT PointedStarter Drill

ACTPSD orRound Drill

RD100



RD100

RequiredStep For

Dense Bone

4mm

Dense BoneTap

NTAP411

20mm

18mm

15mm

13mm

11.5mm

10mm

8.5mm

7mm

ACT Twist DrillDepth Marks

Drill Tip Max1.3mm

Quick Reference Subcrestal Surgical Protocol3i T3TM Tapered 3.25mm(D), 3i T3 Tapered 4mm(D) X 3.4mm(P)

& 3i T3 Tapered 4mm(D) Implants

3.25mm

Quad

Shaping Drill

QSD3285(Final Drill

For Soft

Bone)

The recommended drill speed for all drills is 1200 1500rpm.

The Quad Shaping Drills must be used without pumping actions.

The recommended implant placement speed is 15 20rpm. The implant placement torque may exceed 50Ncm.

Hand ratcheting may be necessary to fully seat the implant in the osteotomy.

Certain Internal Connection Driver Tips should be inspected for wear before use.

It is recommended that reusable drills be replaced after 15 uses.

Tapping is required for implant placement in Dense (Type I) Bone.

IMPORTANT NOTE: Exceeding insertion torque of more than 90Ncm may deform or strip

the driver tip or the implants internal hex and may possibly delay the surgical procedure.

D = DiameterC = CollarP = Platform

L = Length


22/67

The recommended drill speed for all drills is 1200 1500rpm.

The Quad Shaping Drills must be used without pumping actions.

The recommended implant placement speed is 15 20rpm.

The implant placement torque may exceed 50Ncm.

Hand ratcheting may be necessary to fully seat the implant in the osteotomy.



Tapping is required for implant placement in Dense (Type I) Bone.

IMPORTANT NOTE: Exceeding insertion torque of more than 90Ncm may deform or strip

the driver tip or the implants internal hex and may possibly delay the surgical procedure.

19

Quick Reference Subcrestal Surgical Protocol3i T3TM Tapered 5mm(D) X 4.1mm(P), 3i T3 Tapered 5mm(D),

3i T3 Tapered 6mm(D) X 5mm(P) & 3i T3 Tapered 6mm(D) Implants

Tapered 6mm(D) X 5mm(P) & Tapered 6mm(D) Implants

Tapered 5mm(D) X 4.1mm(P) & Tapered 5mm(D) Implants

2mm

Twist Drill

4mm

Quad

Shaping Drill

QSD411

5mm

Quad

Shaping Drill

QSD511

6mm

Quad

Shaping Drill

QSD611

6mm

Depth/

Direction

Indicator

NTDI611

Cover ScrewICSF60

3.25mm

Quad

Shaping Drill

QSD3211

2mm

Twist Dr ill

4mm

Quad

Shaping Drill

QSD411

5mm

Quad

Shaping Drill

QSD585(Final Drill

For Soft

Bone)

5mm

Quad

Shaping Drill

QSD511

Cover Screw

ICSF50

3.25mm

Quad

Shaping Drill

QSD3211

5mm(D) X 5mm(C)

X

4.1mm(P) X 11.5mm(L)

6mm(D)

X

11.5mm(L)

Cover Screw

ICSF41

Cover ScrewICSF50

5mm(D)

X

11.5mm(L)

6mm(D) X 6mm(C)

X

5mm(P) X 11.5mm(L)



RD100

5mm

Depth/

Direction

Indicator

NTDI511



RD100

RequiredStep For

Dense Bone

5mm

Dense Bone

Tap

NTAP511

RequiredStep For

Dense Bone

6mm

Dense Bone

TapNTAP611


D = DiameterC = Collar

P = PlatformL = Length 20mm

18mm

15mm

13mm

11.5mm

10mm

8.5mm

7mm


Drill Tip Max

1.3mm


5mm

Quad

Shaping Drill

QSD685(Final Drill

For Soft

Bone)


23/67

1. Once the implant site has been determined, mark the site with theACT Pointed Starter Drill or Round Drill and penetrate the cortical bone.The recommended drill speed is 1200 1500rpm.

Instrument needed:ACT Pointed Starter Dril l (ACTPSD)

orRound Drill (RD100 or DR100)

2. Proceed with the Initial Twist Drill to approximately 7mm. Continue topenetrate the bone to the desired depth. Set the drill speed at approximately1200 1500rpm.

Instruments needed:2mm Twist DrillDirection Indicator (DI100 or DI2310)

3. Verify the direction and position of the preparation by inserting the thinportion of the Direction Indicator into the osteotomy. Thread a suture

through the hole to prevent accidental swallowing.

At this step, a Gelb Radiographic Depth Gauge may also be used.

Instruments needed:Direction Indicator (DI100 or DI2310)Gelb Radiographic Depth Gauge (XDGxx)

Final Shaping Drill Step Of A3i T3 Tapered 3.25mm(D) Implant

In Soft (Type IV) Bone

In soft bone situations where dense cortical bone is present, it may be

necessary to prepare the coronal aspect of the osteotomy.

4a. After preparing the osteotomy with the 2mm Twist Dril l, finish with a3.25mm x 8.5mm Quad Shaping Drill (QSD3285). This will create anosteotomy of proper dimension in the dense cortical bone to receive theimplant, but will slightly undersize the osteotomy in the cancellous region.The recommended drill speed is 1200 1500rpm.

For a quick reference guide to 3i T3 Tapered

3.25mm(D) Implant placement, please refer

to page 18.

3.4

1.25

1.9

Subcrestal Surgical Protocol3i T3TM Tapered 3.25mm(D) Implants

20


24/67

21

Preparation For Placement Of A3i T3 Tapered 3.25mm(D)

Implant In Soft (Type IV) Bone

4b. Flush the osteotomy with sterile saline solution. Using suction, remove anyremaining drilling debris from the osteotomy before proceeding with theDepth/Direction Indicator (NTDI).

4c. Insert the tapered end of the 3.25mm x 8.5mm (NTDI). This will simulatethe position of the implant platform in relat ion to the crest of the bone. If theposition of the NTDI does not indicate proper osteotomy depth, adjust thedepth of the osteotomy with the 3.25mm x 8.5mm Quad Shaping Drill or

consider a longer length implant if the site has been over prepared. Re-evaluate with the 3.25mm x 8.5mm NTDI. Thread a suture through thehole to prevent accidental swallowing.

Proceed to step 1 on page 33for implant placement.

Final Shaping Drill Step Of A 3i T3 Tapered 3.25mm(D) Implant

In Medium (Type II And Type III) To Dense (Type I) Bone

5a. Resume preparing the osteotomy with the 3.25mm Quad Shaping Drill(QSD32xx) that is the same length as the implant to be placed.

The recommended drill speed is 1200 1500rpm.

Preparation For Placement Of A 3i T3 Tapered 3.25mm(D)

Implant In Medium (Type II And Type III) To Dense (Type I) Bone



(Contd)


25/67

22

Required Step


(Contd)

5c. Insert the tapered end of the 3.25mm (purple) NTDI that corresponds tothe length of the implant to be placed. This wil l simulate the position of the

implant platform in relation to the crest of the bone. If the position of theNTDI does not indicate proper osteotomy depth, adjust the depth of theosteotomy with the corresponding 3.25mm Quad Shaping Drill orconsider a longer length implant if the site has been over prepared. Re-evaluate with a proper length NTDI. Thread a suture through the hole toprevent accidental swallowing.


Required Tapping Step: For Dense (Type I) BoneIf placing a 3i T3 Tapered 3.25mm(D) implant in Dense (Type I) Bone,

tapping with a Dense Bone Tap is required.

Using the Handpiece Connector, advance the tap into the prepared site atapproximately 15 20rpm. It is not uncommon for the drill unit to stallbefore the tap is completely seated. Final seating of the Dense Bone Tapmay require the use of the Ratchet Extension and the Ratchet Wrench.Fully seat the tap to the level demonstrated by the NTDI.

Instruments needed:Handpiece Connector (MDR10)Dense Bone Tap (NTAP32xx)Ratchet Extension (RE100 or RE200)Ratchet Wrench (WR150)


For more information on various bone densities please see page 7.


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23

Subcrestal Surgical Protocol3i T3TM Tapered 4mm(D) X 3.4mm(P) & 3i T3 Tapered 4mm(D)

Implants




2. Proceed with the Initial Twist Drill to approximately 7mm. Continue topenetrate the bone to the desired depth. Set the drill speed atapproximately 1200 1500rpm.






4. Proceed with the 3.25mm Quad Shaping Drill (QSD32xx) that is the samelength as the implant to be placed. The recommended drill speed is1200 1500rpm.

For a quick reference guide to 3i T3 Tapered4mm(D) X 3.4mm(P) and 3i T3 Tapered 4mm(D)

Implant placement, please refer to page 18.

4.1

2.4

1.25

4.1

1.25

2.4

3.4


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24

Final Shaping Drill Step Of A 3i T3 Tapered 4mm(D) X 3.4mm(P)

& 3i T3 Tapered 4mm(D) Implant In Soft (Type IV) Bone

In soft bone situations where dense cortical bone is present, it may benecessary to prepare the coronal aspect of the osteotomy.

5a. After preparing the osteotomy with the 3.25mm Quad Shaping Dril l, finishwith a 4mm x 8.5mm Quad Shaping Dril l (QSD485). This will create anosteotomy of proper dimension in the dense cortical bone to receive theimplant, but will slightly undersize the osteotomy in the cancellous region.


Preparation For Placement Of A 3i T3 Tapered 4mm(D) X 3.4mm(P)



5c. Insert the tapered end of the 4mm x 8.5mm (NTDI485). This will simulatethe posi tion of the implant platform in relation to the crest of the bone. If theposition of the NTDI does not indicate proper osteotomy depth, adjust thedepth of the osteotomy with the 4mm x 8.5mm Quad Shaping Drill orconsider a longer length implant if the site has been over prepared. Re-evaluate with the 4mm x 8.5mm NTDI. Thread a suture through the hole

to prevent accidental swal lowing.



& 3i T3 Tapered 4mm(D) Implant In Medium (Type II And Type

III) To Dense (Type I) Bone

6a. Resume preparing the osteotomy with the 4mm Quad Shaping Drill

(QSD4xx) that is the same length as the implant to be placed.The recommended drill speed is 1200 1500rpm.

Subcrestal Surgical Protocol3i T3TM Tapered 4mm(D) X 3.4mm(P) & 3i T3 Tapered 4mm(D) Implants

(Contd)


28/67

25





6c. Insert the tapered end of the 4mm (blue) NTDI that corresponds to thelength of the implant to be placed. This will simulate the position of theimplant platform in relation to the crest of the bone. If the position of theNTDI does not indicate proper osteotomy depth, adjust the depth of the

osteotomy with the corresponding 4mm Quad Shaping Drill or consider alonger length implant if the site has been over prepared. Re-evaluate with aproper length NTDI. Thread a suture through the hole to preventaccidental swallowing.


Required Tapping Step: For Dense (Type I) BoneIf placing a 3i T3 Tapered 4mm(D) X 3.4mm(P) or 3i T3 Tapered 4mm(D)Implant in Dense (Type I) Bone, tapping with a Dense Bone Tap isrequired. Using the Handpiece Connector, advance the tap into theprepared site at approximately 15 20rpm. It i s not uncommon for the

drill unit to stall before the tap is completely seated. Final seating of theDense Bone Tap may require the use of the Ratchet Extension and theRatchet Wrench. Fully seat the tap to the level demonstrated by the NTDI.




Required Step


(Contd)


29/67

26

5

3.2

1.25

5

3.2

1.25

For a quick reference guide to 3i T3 Tapered

5mm(D) X 4.1mm(P) and 3i T3 Tapered 5mm(D)













4.1


30/67

27

5. Resume preparing the osteotomy with the 4mm Quad Shaping Drill(QSD4xx) that is the same length as the implant to be placed.



& 3i T3 Tapered 5mm(D) Implant In Soft (Type IV) BoneIn soft bone situations where dense cortical bone is present, it may be


6a. After preparing the osteotomy with the 4mm Quad Shaping Drill, finish witha 5mm x 8.5mm Quad Shaping Drill (QSD585). This will create anosteotomy of proper dimension in the dense cortical bone to receive theimplant, but will slightly undersize the osteotomy in the cancellous region.





6c. Insert the tapered end of the 5mm x 8.5mm (NTDI585). This will simulatethe position of the implant platform in relat ion to the crest of the bone. If theposition of the NTDI does not indicate proper osteotomy depth, adjust thedepth of the osteotomy with the 5mm x 8.5mm Quad Shaping Drill orconsider a longer length implant if the site has been over prepared. Re-

evaluate with the 5mm x 8.5mm NTDI. Thread a suture through the holeto prevent accidental swal lowing.



(Contd)


31/67

28


& 3i T3 Tapered 5mm(D) Implant In Medium (Type II And Type III)

To Dense (Type I) Bone

7a. Resume preparing the osteotomy with the 5mm Quad Shaping Drill(QSD5xx) that is the same length as the implant to be placed.The recommended drill speed is 1200 1500rpm.


& 3i T3 Tapered 5mm(D) Implant In Medium (Type II and Type



7c. Insert the tapered end of the 5mm (yellow) NTDI that corresponds to thelength of the implant to be placed. This will simulate the position of theimplant platform in relation to the crest of the bone. If the position of theNTDI does not indicate proper osteotomy depth, adjust the depth of theosteotomy with the corresponding 5mm Quad Shaping Drill or consider alonger length implant if the site has been over prepared. Re-evaluate witha proper length NTDI. Thread a suture through the hole to preventaccidental swallowing.


Required Tapping Step: For Dense (Type I) BoneIf placing a 3i T3 Tapered 5mm(D) X 4.1mm(P) or 3i T3 Tapered 5mm(D)Implant in Dense (Type I) Bone, tapping with a Dense Bone Tap is required.Using the Handpiece Connector, advance the tap into the prepared site atapproximately 15 20rpm. It is not uncommon for the drill unit to stallbefore the tap is completely seated. Final seating of the Dense Bone Tapmay require the use of the Ratchet Extension and the Ratchet Wrench.

Fully seat the tap to the level demonstrated by the NTDI.



For more information on variousbone densities please see page 7.

Required Step


(Contd)


32/67

29

3.9

6

5

1.25

3.9

For a quick reference guide to 3i T3 Tapered6mm(D) X 5mm(P) and 3i T3 Tapered 6mm(D)







3. Verify the direction and position of the preparation by insert ing the thinportion of the Direction Indicator into the osteotomy. Thread a suture





6

1.25

Subcrestal Surgical Protocol3i T3TM Tapered 6mm(D) X 5mm(P) & 3i T3 Tapered 6mm(D) Implants


33/67

30


(Contd)

5. Resume preparing the osteotomy with the 4mm Quad Shaping Drill(QSD4xx) that is the same length as the implant to be placed.


6. Resume preparing the osteotomy with the 5mm Quad Shaping Drill(QSD5xx) that is the same length as the implant to be placed.The recommended drill speed is 1200 1500rpm.

Final Shaping Drill Step Of A 3i T3 Tapered 6mm(D) X 5mm(P)

& 3i T3 Tapered 6mm(D) Implant In Soft (Type IV) BoneIn soft bone situations where dense cortical bone is present, it may be


7a. After preparing the osteotomy with the 5mm Quad Shaping Drill, finish witha 6mm x 8.5mm Quad Shaping Drill (QSD685). This will create anosteotomy of proper dimension in the dense cortical bone to receive theimplant, but will slightly undersize the osteotomy in the cancellous region.The recommended drill speed is 1200 1500rpm.

Preparation For Placement Of A 3i T3 Tapered 6mm(D) X 5mm(P)


7b. Flush the osteotomy with sterile saline solution. Using suction, remove anyremaining drilling debris from the osteotomy before proceeding with the

Depth/Direction Indicator (NTDI).


34/67

31


(Contd)

7c. Insert the tapered end of the 6mm x 8.5mm (NTDI685). This will simulatethe position of the implant platform in relation to the crest of the bone. If the

position of the NTDI does not indicate proper osteotomy depth, adjust thedepth of the osteotomy with the 6mm x 8.5mm Quad Shaping Drill orconsider a longer length implant if the site has been over prepared. Re-evaluate with the 6mm x 8.5mm NTDI. Thread a suture through the hole toprevent accidental swallowing.


Final Shaping Drill Step Of A 3i T3 Tapered 6mm(D) X 5mm(P)



8a. Resume preparing the osteotomy with the 6mm Quad Shaping Drill(QSD6xx) that is the same length as the implant to be placed.The recommended drill speed is 1200 1500rpm.

Preparation For Placement Of A 3i T3 Tapered 6mm(D) X 5mm(P)& 3i T3 Tapered 6mm(D) Implant In Medium (Type II And Type



8c. Insert the tapered end of the 6mm (green) NTDI that corresponds to thelength of the implant to be placed. This will simulate the position of theimplant platform in relation to the crest of the bone. If the position of theNTDI does not indicate proper osteotomy depth, adjust the depth of theosteotomy with the corresponding 6mm Quad Shaping Drill or consider alonger length implant if the site has been over prepared. Re-evaluate with

a proper length NTDI. Thread a suture through the hole to preventaccidental swallowing.



35/67

32

Required Step


(Contd)

Required Tapping Step: For Dense (Type I) Bone

If placing a 3i T3 Tapered 6mm(D) X 5mm(P) or 3i T3 Tapered 6mm(D)Implant in Dense (Type I) Bone, tapping with a Dense Bone Tap is required.Using the Handpiece Connector, advance the tap into the prepared site atapproximately 15 20rpm. It is not uncommon for the drill unit to stallbefore the tap is completely seated. Final seating of the Dense Bone Tapmay require the use of the Ratchet Extension and the Ratchet Wrench.Fully seat the tap to the level demonstrated by the NTDI.





36/67

33

Subcrestal Implant Placement Protocol3i T3TM Tapered Implants

No-Touch Delivery System

1. Remove contents from the implant box.

2. The nonsterile assistant should peel back the tray lid and drop theNo-Touch Implant Tray onto the sterile drape.

3. Place the No-Touch Implant Tray into the appropriate location on thesurgical tray.

4. Peel back the tray lid to expose the implant and cover screw.


37/67

34

Instructions Specific For A 3i T3 Tapered 4mm(D) X 3.4mm(P)& 3i T3 Tapered 3.25mm(D) Implant

5. Pick up the implant from the surgical tray using the dedicated Certain

Implant Placement Driver Tip. Carry the implant to the mouth facing upwardto prevent accidental dislodging. See page 59 for addit ional implant drivertechnical tips.

Due to wear, periodic O-Ring replacement is required for the Certain InternalConnection Driver Tip. Certain Internal Connection Driver Tips should beinspected for wear before use.

Instrument needed:Dedicated Certain Standard 3.25mm(D) Driver Tip (IMPDTS or IMPDTL)

NOTE: The 3i T3 Tapered 4mm(D) X 3.4mm(P) and 3i T3 Tapered

3.25mm(D) Implants require the use of a dedicated Certain 3.4mm(D)Driver Tip (IMPDTS or IMPDTL) that is marked with a purple band on the

shank. The internal connection configuration of these implants is smaller

than standard 4, 5 and 6mm(D) implants. The item numbers can be

identified on the side of the driver tip.

Proceed to step 6.

Instructions Specific For A Larger Diameter 3i T3 Tapered Implant

5. Pick up the implant from the surgical tray using the dedicated Certain ImplantPlacement Driver Tip. Carry the implant to the mouth facing upward toprevent accidental dislodging. See page 59 for additional implant driver

technical tips.

Due to wear, periodic O-Ring replacement is required for the Certain InternalConnection Driver Tip. Certain Internal Connection Driver Tips should beinspected for wear before use.

Instrument needed for 3i T3 Tapered 5mm(D) X 4.1mm(P), 6mm(D) X5mm(P) and 3i T3 Tapered 4, 5 and 6mm(D) Implants:

Implant Placement Driver Tip (IIPDTS or IIPDTL)

6. Place the implant into the prepared site at approximately 15 20rpm.It is not uncommon for the handpiece to stall before the implant iscompletely seated. The implant position must match what was simulated

with the Depth/Direction Indicator (NTDI) or there is a risk of a poor fi t

between the implant and osteotomy. In Dense (Type I) Bone, it is required totap the site with a Dense Bone Tap prior to implant placement.

Subcrestal Implant Placement Protocol (Contd)3i T3TM Tapered Implants


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7. Final seating of the implant may require the use of the Ratchet Extension andthe Ratchet Wrench.

Instruments needed:Ratchet Wrench (WR150) orHigh Torque Indicating Ratchet Wrench (H-TIRW)Certain Universal Ratchet Extension (IRE100U or IRE200U)

8. To remove the Certain Universal Ratchet Extension from the implant, lift itstraight up and out.

9. If performing a two-stage surgical protocol, pick up the Cover Screw fromthe No-Touch Implant Tray with the Implant Placement Driver Tip or LargeHex Driver and place onto the implant.

NOTE: When using the Certain Implant Placement Driver, reduce the

torque setting on the drill unit to 10Ncm.

Instruments needed:Implant Placement Driver Tip (IIPDTS or IIPDTL)Large Hex Driver (PHD02N)

10. Reposition the soft-tissue flaps and secure with sutures.

Subcrestal Implant Placement Protocol (Contd)3i T3TM Tapered Implants


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*Discrete Crystalline Deposition (DCD) is a process

by which the implant surface is treated with a nano-scale

deposition of biocompatible calcium phosphate crystals.

Parallel Walled Implants

3i T3


3i T3

Standard Collar

3i T3 with DCD*


3i T3 with DCD*

Standard Collar


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Twist Drill Depth Marking System3i T3TM Parallel Walled Implants

ITD Reusable Drills

Internal irrigation lumen All thin lines

Types Of Twist Drills

DT & DTN Disposable Drills

Without internal irrigation lumen Bands DTN disposable drills do not

have a hub

ACT Drill Marks

8.5mm

7mm

Drill Tip

10mm

11.5mm

13mm

15mm

Max 1.3mm

The length of the drill tip is not includedin the depth mark measurement.The drill tip length should be considered

when preparing the osteotomy.

The length of the drill tip varies with thediameter of the drill.

The center of the drills single line depthmarks and the beginning or end of thebroad band indicate subcrestal placement

for the corresponding length implant.

Drill Tip Dimensions

ACT Reusable Drills

Without internal irrigation lumen Alternating lines and bands No hub

Drill Diameter

ITD/DTN/DT

Drill Tip Length

ACT

Drill Tip Length

2mm 0.6mm 0.6mm

2.3mm 0.7mm N/A

2.75mm 0.8mm 0.9mm3mm 0.9mm 0.9mm

3.15mm 1mm 1mm

3.25mm 1mm 1mm

3.85mm N/A 1.2mm

4.25mm 0.4mm 1.3mm

4.85mm N/A 1.3mm

5.25mm 0.5mm 1.2mm

A 2mm Twist Dril l is used to prepare the osteotomy forthe sequent ial Quad Shaping Drills (QSDs) in each of thetapered surgical protocols.

Pages 38-41 outline the guidelines for understanding thedepth markings on the Twist Drill System.


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Twist Drill Depth Marking System (Contd)3i T3TM Parallel Walled Implants

The Depth Marks measurement systemprovides a mark on the drill that corresponds to theplacement of the implant via well-establishedprocedures. BIOMET 3is original protocol follows theprinciples of protecting the implant from prematureloading by placing the implant subcrestally.

Drilling DepthThe drilling depth with the Twist Drill will varydepending on the type of placement related to thebone crest.

The depth marks are specific for subcrestal implantplacement only. There are no specific depth marks on

the drills for crestal or supracrestal placement.

The drill depth marks do not indicate implant lengths.Rather, the drill depth marks represent the length of

the implant with a standard 1mm cover screw in place.As a result, to place an implant and cover screwsubcrestallyrequires drilling to the middle of thesingle line depth mark or the beginning or end of thebroad band depth mark on ACT Drills. For crestalplacement, drill halfway before the correspondingdepth mark for the implant length. For supracrestalplacement, the drill depth mark should remain above

the bone by 1mm for the cover screw plus the implantcollar height. Please refer to the diagram at the bottom

of page 40 for more information on supracrestalplacement.

Implants are packaged with a 0.4mm Cover Screw.However, the protocols for these implants do notdiffer from the protocols for BIOMET 3i Implantspackaged with a 1mm Cover Screw.

Drill TipMax 1.3mm

2mm

Twist Drill

Depth Gauge Implant With A

1mm Cover Screw

SubcrestalCrestalSupracrestal

Standard Subcrestal Protocol -1mm Cover Screw

Drilling Depth Comparison


L = Length


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Labeled vs. Actual Lengths

Drill TipMax 1.3mm

The center of the drills singleline depth marks and thebeginning or end of the broadband indicate the length of theimplant with a standard 1mmcover screw in place.

The actual implant lengths from thetop of the implant collar (p latform)to the tip of the implant are shorterby 0.4mm than the labeled length.

The landmarks (grooves) onthe Certain Implant DriverTip act as references duringimplant placement.


15mm

LabeledLengths

Actual Implant Lengths With

Full Cover Screw ON

15mm

13mm

11.5mm

10mm

8.5mm

7mm

13mm

11.5mm

10mm

8.5mm

7mm

Subcrestal

Crestal

OptionalCoverScrew

SuppliedCoverScrew

Subcrestal Placement

The implant platform will be 1mm (or more) below the bone crest.

Mostly used in the anterior region for aesthetics.

8.5mm

7mm

1mm

Subcrestal

10mm

Bone Crest For subcrestal implant placement, drill tothe drill depth mark that corresponds tothe labeled implant length.

11.5mm

Drill TipMax 1.3mm



L = Length


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Crestal Placement

The implant platform will be at the bone crest.

For crestal implant placement, stopdrilling 1mm beforethe dril l depth mark

that corresponds to the labeled implantlength (1mm equals the traditionalcover screw height).

Supracrestal Placement

The implant collar will be above the bone crest. For supracrestal implant placement,stop drilling 2.25mm before the drilldepth mark that corresponds to thelabeled implant length (2.25mm equals

the 1mm traditional cover screw heightplus the 1.25mm implant collar height).

NOTE: A Countersink Drill is not

needed for internal or external

connection supracrestal implant

placement.

Drill TipMax 1.3mm

Drill TipMax 1.3mm

8.5mm

7mm

1mm

Crestal

10mmBone Crest

11.5mm

8.5mm

7mm

1.25mm

Collar

Height

Supracrestal

10mm Bone Crest

11.5mm




L = Length


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Countersink Drill Depth Marking System

A Counters ink Dril l is used when placing 3i T3 Parallel Walled 4mm(D) X 3.4mm(P), 5mm(D) X 4.1mm(P), 6mm(D) X 5mm(Pand 3i T3 Parallel Walled 4mm, 5mm and 6mm(D) Implants subcrestally to prepare the bone to accept the implant collar.

For crestal placement of the implant, a Countersink Drill may be needed in dense bone due to the shape of the implant collar.

CD500or

CD600

CD500

or

CD600

Bone Crest

Subcrestal Crestal

ICD100ICD100

Subcrestal Crestal

Subcrestal, Crestal & Supracrestal Placement Comparison

Bone Crest

Supracrestal

Drill TipMax 1.3mm


11.5mm(L) 3i T3 Implant11.5mm(L) 3i T3 Implant


11.5mm(L) 3i T3 Implant11.5mm(L) 3i T3 Implant

L = Length


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Quick Reference Subcrestal Surgical Protocol3i T3TM Parallel Walled 3.25mm(D), 3i T3 Parallel Walled

4mm(D) X 3.4mm(P) & 3i T3 Parallel Walled 4mm(D) Implants

20mm

18mm

15mm

13mm

11.5mm

10mm

8.5mm

7mm


Drill Tip Max1.3mm

The recommended drill speed for drills 3.85mm diameter or smaller is 1200 1500rpm.

The recommended drill speed for drills 4.25mm diameter or larger is 900rpm.

The implant placement torque may exceed 50Ncm.

The recommended implant placement speed is 15 20rpm. Final Twist Drill selection is based on clinician evaluation of bone quality.

Hand ratcheting may be necessary to fully seat the implant into the osteotomy.



Tapping is required in dense (Type I) bone for 3i T3 Parallel Walled 5mm, 6mm, 5/4mm and

6/5mm diameter implants.

D = Diameter

C = CollarP = PlatformL = Length

Parallel Walled 3.25mm(D) Implants

3.25mm(D) X 11.5mm(L)



RD100

2mmTwist Drill

Pilot Drill

PD100

(Final Drill ForSoft Bone)

2.75mmTwist Drill

(Medium Bone)

3mm

Twist Drill(Dense Bone)

3.25mm

Dense Bone TapMTAP1

(Optional)

Cover Screw

IMMCS1

IMPORTANT NOTE:

Exceeding insertion torqueof more than 90Ncm maydeform or strip the drivertip or the implants internalhex and may possibly delay

the surgical procedure.



Parallel Walled 4mm(D) X 3.4mm(P) & Parallel Walled 4mm(D) Implants

4mm(D) X 4.1mm(C)

X

3.4mm(P) X 11.5mm(L)

2mm

Twist Drill

Pilot Drill

PD100

2.75mm

Twist Drill

(Soft Bone)

3mm

Twist Dr ill

(Medium Bone)

3.25mm

Twist Drill

(Dense Bone)

4.1mm

Countersink

Drill

ICD100

4mm(D) X 11.5mm(L)

4mm

Dense Bone Tap

TAP413

(Optional)

Cover Screw

IMCSF34Cover Screw

ICSF41



RD100


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The recommended drill speed for drills 3.85mm diameter or smaller is 1200 1500rpm.

The recommended drill speed for drills 4.25mm diameter or larger is 900rpm.

The implant placement torque may exceed 50Ncm. The recommended implant placement speed is 15 20rpm.

Final Twist Drill selection is based on clinician evaluation of bone quality.

Hand ratcheting may be necessary to fully seat the implant into the osteotomy.



Tapping is required in dense (Type I) bone for 3i T3 Parallel Walled 5mm, 6mm, 5/4mm and

6/5mm diameter implants.



Quick Reference Subcrestal Surgical Protocol3i T3TM Parallel Walled 5mm(D) X 4.1mm(P), 3i T3 Parallel Walled 5mm(D),

3i T3 Parallel Walled 6mm(D) X 5mm(P) & 3i T3 Parallel Walled 6mm(D) Implan

Parallel Walled 6mm(D) X 5mm(P) & Parallel Walled 6mm(D) Implants

5mm(D) X 11.5mm(L)5mm(D) X 5mm(C)

X

4.1mm(P) X 11.5mm(L)

2mm

Twist Drill

Pilot Drill

PD100

5mm

Countersink

Drill

CD500(Final Drill For

Soft Bone)

3.85mmTwist Drill

(MediumBone)

4.25mm

Twist Drill(Dense Bone)

3.25mm

Twist DrillCover Screw

ICSF41



RD100

Cover ScrewICSF50

Required for usein dense bone

5mm

Dense Bone Tap

XTAP53S

2mm

Twist Drill

Pilot Drill

PD100

5mm

Countersink

Drill CD500

6mmCountersink Drill

CD600(Final Drill For

Soft Bone)3.25mm

Twist Drill

4.85mm

Twist Drill(Medium

Bone)

5.25mm

Twist Drill

(Dense

Bone)

6mm(D) X 11.5mm(L)

Cover ScrewICSF50



RD100

4.25mm

Twist Drill

Cover Screw

ICSF60

6mm(D) X 6mm(C)

X

5mm(P) X 11.5mm(L)

Required for use

in dense bone

6mm

Dense Bone Tap

XTAP63S

Parallel Walled 5mm(D) X 4.1mm(P) & Parallel Walled 5mm(D) Implants

D = Diameter

C = Collar

P = PlatformL = Length

IMPORTANT NOTExceeding insertion to

of more than 90Ncm m

deform or strip the dr

tip or the implants int

hex and may possibly d

the surgical procedure

20mm

18mm

15mm

13mm

11.5mm

10mm

8.5mm

7mm


Drill Tip Max1.3mm


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Instrument needed:ACT Pointed Starter Drill (ACTPSD)


2. Proceed with the Initial Twist Drill to approximately 7mm, then verify thedirection with the thin portion of the Direction Indicator.

Continue to advance the drill into the osteotomy to the desired depth.The recommended drill speed is 1200 1500rpm.






4. Use the Pilot Drill to shape the coronal aspect of the implant site.Drill to the depth mark. The recommended drill speed is 1200 1500rpm.

For soft (Type IV) bone, this is the final drill. Proceed to step1 on page 53for implant placement.

Instrument needed:Pilot Drill (PD100 or DP100)

44

Subcrestal Surgical Protocol3i T3TM Parallel Walled 3.25mm(D) Implants

1.5

2.4

For a quick reference guide to 3i T3 Parallel

Walled 3.25mm(D) Implant placement,please refer to page 42.

3.4


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5. Once proper alignment is verified using the Direction Indicator, proceed withthe 2.75mm Twist Dril l to the desired depth for implant placement in

medium bone (Type II and III). Proceed with the 3mm Twist Drill to thedesired depth for implant placement in Dense (Type I) Bone.The recommended drill speed is 1200 1500rpm.

Instruments needed:2.75mm Twist Drill for medium (Type II and III) bone3mm Twist Drill for dense (Type I) bone

Optional Tapping Step: For Dense (Type I) BoneIf placing a 3i T3 Parallel Walled 3.25mm(D) Implant in Dense (Type I) Bone,using a Bone Tap is recommended.

Using the Handpiece Connector, advance the tap into the prepared site atapproximately 15 20rpm. It is not uncommon for the drill unit to stall before

the tap is completely seated. Final seating of the Dense Bone Tap may require theuse of the Ratchet Extension and the Ratchet Wrench.

Instruments needed:Handpiece Connector (MDR10)Bone Tap (MTAP1 or MTAP2)Ratchet Wrench (WR150)Ratchet Extension (RE100 or RE200)


For more information on various bone densities, please see page 7.

Optional Step

Subcrestal Surgical Protocol3i T3TM Parallel Walled 3.25mm(D) Implants

(Contd)

7/22/2019 3i T3 Implant Surgical Manual_CATMT3_

3i T3 Implant Surgical Manual_CATMT3_EN

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