Post on 24-Mar-2016
description
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BIOMATERIAL COLLECTION
Allograft
INDEX
DirectOss™DirectGen™DirectGen™ PuttyDirectGen™ FLEXDirectGen™ DERMBioResorb® Macro Pore
12-3
4567
PAGE
Availability Not all products listed in this catalog are available in all countries. Please contact Implant Direct or your local dealer for more information on product availability.
GRAFTING
MEMBRANES
Resorbable
Non-Resorbable
Kontour™ Adapt Kontour™ SustainCytoPlast® RTMCytoPlast® TI250, TXT & GBR
SUTURES
89
1011
ResorbableNon-Resorbable
Vilet™CytoPlast®
1314
Bone GraftingBone GraftingBone GraftingBone GraftingSoft Tissue GraftingBone GraftingSynthetic
Xenograft
WOUND DRESSINGS
Resorbable BIO-XC™ Plug BIO-XC™ Foam BIO-XC™ Tape
12Xenograft
DirectOss™BONE GRAFTING - XENOGRAFT
ANORGANIC CANCELLOUS GRANULES
• 100% natural hydroxyapatite extracted from bovine cancellous bone
• Derived from BSE-free herds in Australia
• Mimics human bone both structurally and chemically
• Sintered at a low temperature to reduce crystallinity content
• Supports new bone in-growth throughout each granule due to its
interconnected macro, meso and micro pore structure
• Packaged in both vials and syringes for easy delivery
• Gamma irradiated to SAL 10-6 for sterility
DirectOss allows you slow resorbing support for integrative new bone growth enabling you to treat bony defects with confidence. This natural hydroxyapatite extracted from bovine cancellous bone boasts greater inner surface area than comparable materials on the market – giving it more space for osteoblast adhesion as well as high hydrophilicity for rapid vascularization.
COMMON APPLICATIONS
Socket preservation
Maxillary sinus floor elevation
Alveolar ridge augmentation
Periodontal regeneration
Defects associated with implants
0.25-1.0mm0.25-1.0mm0.25-1.0mm0.25-1.0mm
Granule Size Weight
0.25g0.50g1.0g2.0g
Packaging
VialVialVialVial
Reference #
DXCA251025DXCA251005DXCA251010DXCA251020
0.25-1.0mm0.25-1.0mm0.25-1.0mm
0.25cc (≈0.125g)0.5cc (≈0.25g)1.0cc (≈0.5g)
SyringeSyringeSyringe
DXCA251025SDXCA251005SDXCA251010S
1.0-2.0mm1.0-2.0mm
0.50g2.0g
VialVial
DXCA102005DXCA102020
100
80
60
40
20
0
Inne
r Sur
face
Are
a (m
2/g)
88.2
79.7
57.0
DirectOss™ Bio-Oss™ NuOss™
Ref. NuOss, a Bone Grafting Material for Oral Surgery: A Comparative Study with BioOss by Collagen Matrix Inc. Ref. Biomaterials 2001; 22:1005-1012
DirectOss has up to 55% greater inner surface to support new bone in-growth
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DirectGen™BONE GRAFTING-ALLOGRAFT
DirectGen™ Allograft is a natural, safe and easy to use grafting material. This product comes in a variety of donated tissue types (cortical, cancellous or cortical-cancellous blend) and is suited for a wide range of clinical needs.
Cancellous Particulate
DirectGen Mineralized cancellous particulate has the interconnecting porosity associated with trabecular bone structure. This allows for increased capillary action of the blood which in turn promotes rapid formation of osteoblasts for new bone growth.
• Has increased porosity and surface area which promotes revascularization and supports in-growth of new bone
Cortical Particulate
DirectGen Mineralized cortical particulate offers the structural strength and integrity associated with cortical bone. This results in a slower resorbing graft material that is ideal for space maintenance in grafting procedures.
• Provides longer lasting scaffold for new bone ingrowth
Cortical-Cancellous Blend
DirectGen Mineralized Blend is a 50:50 mixture of cortical and cancellous particulate. This pre-mixed, easy to use product is intended to provide the clinician with the features and benefits of both tissue types.
• Simplifies procedure by eliminating need to mix tissues chairside
• Single donor per vial
DirectGen has been processed utilizing a proprietary process. This process allows for microbial inactivation while minimally manipulating the tissue. This process meets or exceeds requirements set forth by the FDA and American Association of Tissue Banks (AATB) and in addition, there have been no confirmed cases of disease transmission from allografts in its extensive history.
Demineralized Cortical Particulate
DirectGen Demineralized particulate has been processed to expose the bone morphogenic proteins within the bone matrix. This results in a graft material that has the potential to induce cell differentiation and new bone formation.
• Each lot is tested via BMP-2 assay POST sterilization
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DirectGen Mineralized/Demineralized Cortical Combo
DirectGen Mineralized/Demineralized Cortical Combo is a 50:50 combination of mineralized cortical tissue and demineralized cortical tissue. This pre-mixed combination results in a material with osteoconductive properties as well as osteoinductive potential.
• Saves time and effort by eliminating need to mix tissues chairside
• Mineralized content ideal for space maintenance while demineralized content provides osteoinductive potential
Allograft: DirectGen Demineralized Cortical Item#
(125-850μm) - 0.5cc DDCOR128505
(125-850μm) - 1.0cc DDC0R128510
(125-850μm) - 2.0cc DDCOR128520
Allograft: DirectGen Mineralized Cortical Item#
(250-1000μm) - 0.5cc DCOR251005
(250-1000μm) - 1.0cc DCOR251010
(250-1000μm) - 2.0cc DCOR251020
(1000-2000μm) - 0.5cc DCOR102005
(1000-2000μm) - 1.0cc DCOR102010
(1000-2000μm) - 2.0cc DCOR102020
Allograft: DirectGen Mineralized Cancellous Item#
(250-1000μm) - 0.5cc DCAN251005
(250-1000μm) - 1.0cc DCAN251010
(250-1000μm) - 2.0cc DCAN251020
(1000-2000μm) - 0.5cc DCAN102005
(1000-2000μm) - 1.0cc DCAN102010
(1000-2000μm) - 2.0cc DCAN102020
Allograft: DirectGen Mineralized Cortical/Cancellous blend Item#
(250-1000μm) - 0.5cc DBLN251005
(250-1000μm) - 1.0cc DBLN251010
(250-1000μm) - 2.0cc DBLN251020
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Allograft: DirectGen Mineralized/ Demineralized Cortical Combo Item#
(125-1000μm) - 0.5cc DCMB121005
(125-1000μm) - 1.0cc DCMB121010
(125-1000μm) - 2.0cc DCMB121020
DirectGen Packaging
DirectGen™ PUTTYBONE GRAFTING - PUTTY
DEMINERALIZED PUTTY
• Made from 100% human bone – nothing added that may get in the way of bone healing
• Osteoconductive – DBM provides an ideal scaffold that directs and supports bone formation
• Osteoinductive – the osteoinductive potential of DBM is well established
• Excellent handling characteristics – will shape and conform to fill unique bony voids, retains
shape and resists wash-out, or migration, from graft site
• Easy to store and use – stores at ambient room temperature, long three-year shelf life, and
ready for immediate use; no prep time or reconstitution required
• Sterile – gamma irradiated to SAL 10-6
• Safe – donor recovery and screening performed according to AATB and FDA guidelines
• Clinically versatile – available in a flowable putty or as a flowable putty plus mineralized chips
Available in two options and a variety of sizes:
Innovation often follows the straightest path. In bone grafting, attention to basic fundamentals has always been the key to the best and most predictable clinical outcomes. Historically, bone itself is the best substrate for new bone formation. This is the philosophy behind DirectGen Putty, which is simply comprised of human bone and buffered water.
DirectGen Putty Size
DP070 0.7cc
DP100 1.0cc
DP250 2.5cc
DirectGen Putty PLUS Size
DPP100 1.0cc
DPP250 2.5cc
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DirectGen™ FLEXBONE GRAFTING - ALLOGRAFT
DEMINERALIZED CORTICAL ALLOGRAFT SHEET
• Proprietary processing leaves cortical sheet flexible which allows it to
be easily adapted to act as missing wall in 3 wall defect or as an onlay
to cover a graft site
• Product retains enough rigidity to allow it to be easily tucked into
periosteal envelope (as compared to a membrane) and maintains its
position during flap closure and suturing
• Rehydrates in minutes and can be easily shaped with scissors or
scalpel. Can be tacked or sutured
• Provides 3 dimensional osteoconductive scaffold that promotes
revascularization and in-growth of new bone
• Demineralization process exposes BMP-2 content native in the tissue.
Each LOT is assayed and tested for its osteoinductive potential post
sterilization
COMMON APPLICATIONS
Repair of 3 wall defects
Repair of access windows
Ridge Augmentations
10mm x 10mmDFLX1010
(1/box)
10mm x 17mmDFLX1017
(1/box)
15mm x 15mmDFLX1515
(1/box)
DirectGen FLEX inserted subperiostelly to act as temporary wall
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DirectGen™ DERMSOFT TISSUE GRAFTING - ALLOGRAFT
DECELLURIZED DERMAL ALLOGRAFT TISSUE
• Biocompatible
• Retains collagen and elastin and has elasticity of the native dermis
• Processing preserves biologic properties that promote revascularization
and repair of damaged tissues
• Eliminates morbidity and pain associated with a donor site
• Allows multiple sites to be treated in same surgery
• Proprietary processing allows either side to be placed against defect.
No special orientation required
• Rehydrates in minutes and is easily trimmed with scalpel or scissors
• Retains enough firmness when hydrated to facilitate easy placement
in graft site (especially when used for tunnel technique)
Pre-op DirectGen DERM trimmed for site
Insertion of DirectGen DERM Site sutured 4 week post-op
Available in multiple thickness and size options:
Thin (0.5-1.0mm) Size
DD101005 10x10mm
DD102005 10x20mm
DD104005 10x40mmDD204005 20x40mm
Thick (1.0-1.5mm) Size
DD101010 10x10mm
DD102010 10x20mm
DD104010 10x40mmDD204010 20x40mm
Case courtesy of Avi Schetritt, DMD
βioResorb® Macro PoreBONE GRAFTING-SYNTHETIC
β-TRICALCIUM PHOSPHATE BONE REGENERATION MATERIAL WITH ADVANCED POROSITY βioResorb® Macro Pore is an osteoconductive, pure-phase β-Tricalcium phosphate bone grafting material developed via a patented process that creates a porous structure most similar to human bone. The interconnecting micro & macro porous structure gives the advantage of allowing vascularization and cell transport into and throughout the particle, leading to new bone deposits within the particles themselves.
Histology at 7 months – improved bone regeneration
with a high activity of osteoblasts, homogenous cortical
structures and no signs of inflammation. Odontogenic keratocyst 6 months after cyst removal
and placement of βioResorb®
Macro Pore. Complete
restitution of bone structure.
βioResorb Macro Pore is made from 99% pure-phase Beta Tri-Calcium Phosphate (β-TCP). Each batch of product is tested via X-ray diffraction to ensure its purity. In addition, the calcium/phosphor atom ratio in βioResorb is 1.5 (very similar to the mineral phase of human bone which is 1.6).
200-500μm 0.5ml 19002105
500-1000μm 0.5ml 19005105
1.0ml 19005110
2.0ml 19005120
βioResborb Macro Pore Single pack (1 vial/1 box) Item#
1400-3200μm 1.0ml 19014110
200-500μm 0.5ml 19002505
500-1000μm 0.5ml 19005505
1.0ml 19005510
2.0ml 19005520
βioResborb Macro Pore 5- pack (5 vials/1 box) Item#
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MEMBRANES
Kontour™ AdaptRESORBABLE MEMBRANE
TYPE I PORCINE PERITONEUM COLLAGEN RESORBABLE MEMBRANE
• Resorbable; new host collagen is regenerated as membrane resorbs
• Easy to use; not side specific and easily conforms to defects and contours
• Can be used dry or hydrated. Membrane does not stick to instruments or
gloves when hydrated and can be easily repositioned once placed
• Membrane’s proprietary process assures the membranes are highly
biocompatible resulting in minimal inflammation and foreign body response
• Membrane has excellent strength to support tacking or suturing
• Initial slower rate of resorption protects wound during early critical
period of healing
• Protects wound from undesired in growth of soft tissue
• Provides effective barrier functionality for up to 12 -16 weeks
COMMON APPLICATIONS
Periodontal defects
Sinus lift osteotomies
Repair of access windows
Soft tissue augmentation
Periapical lesions
KRMA1520KRMA2030KRMA3040
Reference# Description
15x20mm membrane (1/box)20x30mm membrane (1/box)30x40mm membrane (1/box)
SEM micrograph of the Kontour Adapt (side A) at 50x magnification
SEM micrograph of the Kontour Adapt (side B) at 50x magnification
SEM micrograph of the Kontour Adapt (cross-section) at 50x magnification
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Kontour™ SustainRESORBABLE MEMBRANE
TYPE I PORCINE COLLAGEN RESORBABLE MEMBRANE
• Fully Resorbable; no second surgery required
• Easy to use; either side may be placed against defect
• Can be used dry or hydrated. Hydrates in minutes. Membrane does
not stick to itself when hydrated allowing for easy placement
and/or repositioning
• Membrane retains sufficient memory when hydrated which allows it to
be easily positioned under the periosteum uniformly without bunching
up. This also allows the membrane to maintain its shape and position
during closing, suturing and throughout its use
• Membrane is also soft and conformable. This allows membrane to adapt
well to most varying bone topographies
• Unique fiber orientation provides membrane with high tensile strength
and high suture pullout resistance
• Provides effective barrier functionality for 16-24 weeks
COMMON APPLICATIONS
Periodontal defects
Sinus lift osteotomies
Repair of access windows
Soft tissue augmentation
Periapical lesions
15mm x 20mmKRM1520
(1/box)
20mm x 30mmKRM2030
(1/box)
30mm x 40mmKRM3040
(1/box)
50X Magnification
9 www.implantdirect.com
CytoPlast® RTMRESORBABLE MEMBRANE
TYPE I BOVINE COLLAGEN RESORBABLE TISSUE MATRIX
• Resorbable; eliminates second surgery
• Unique fiber orientation provides unusually high tensile strength
• Safe; manufactured from highly purified Type I bovine achilles tendon
• Layered construction allows cellular ingrowth of outer layer, but inner layers
help prevent cellular and bacterial downgrowth
• Longer predictable resorption time of 26 to 38 weeks
• Guides healing of bone and surrounding tissue
• High mechanical strength for membrane stabilization using either sutures or resorbable tacks
• Excellent handling when wet, and either side can be placed against the defect
• Optimized flexibility and rigidity for better maintenance of space
This cross sectional SEM view demonstrates the multi-layer construction allowing tissue integration in outer layer while preventing direct passage of bacteria and epithelial cells.
CYTOPLAST® RTM COLLAGEN
COMMON APPLICATIONS
Periodontal defects
Sinus lift osteotomies
Repair of access windows
Soft tissue augmentation
Periapical lesions
15mm x 20mmRTM1520
(2/box)
20mm x 30mmRTM2030
(2/box)
30mm x 40mmRTM3040
(2/box)
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CytoPlast® TI250, TXT & GBRNON-RESORBABLE AND NON-RESORBABLE TITANIUM REINFORCED MEMBRANES
THE ORIGINAL, PATENTED, HIGH-DENSITY PTFE MEMBRANE
• Non-resorbable; won’t resorb prematurely leaving graft site exposed
• Made from d-PTFE; <0.3um pore size is impervious to bacteria
• Primary closure not required; less surgical time required
• Soft tissue attaches but does not grow through membrane; allows for
non-surgical removal
• Textured surface; increases membrane stabilization
• Titanium Insert (on TI250 membranes) provides membrane with shape memory
and rigidity for superior space creation and maintenance while grafting
This SEM view shows the micro-machined textured surface, which increases the area available for cellular attachment by 250% without increasing porosity.
Cytoplast Ti250 Anterior SingleTi250AS-1 (1 membrane/box) Ti250AS-2 (2 membranes/box)
Ideal size and shape for single-tooth extraction sites, especially where one or more bony walls are missing.
14mm x 24mm
Cytoplast Ti250 Anterior Narrow Ti250ANL-1 (1 membrane/box) Ti250ANL-2 (2 membranes/box)
Ideal for narrow single-tooth extraction sites, especially where one or more bony walls are missing.
12mm x 24mm
Cytoplast Ti250 BuccalTi250BL-1 (1 membrane/box)Ti250BL-2 (2 membranes/box)
Ideal for use in large buccal defects. The pilot holes create more secure membrane stabilization.
17mm x 25mm20mm x 25mm
Cytoplast Ti250 Posterior Singles Ti250PS-1 (1 membrane/box)Ti250PS-2 (2 membranes/box)
Designed for grafting posterior extraction sites and limited ridge augmentation.
25mm x 30mm
Cytoplast Ti250 Posterior LargeTi250PL-1 (1 membrane/box) Ti250PL-2 (2 membranes/box)
Designed for grafting large bony defects, including ridge augmentation.
CYTOPLAST® TI250
Cytoplast TXT253025mm x 30mm(4 membranes/box)
Cytoplast TXT122412mm x 24mm(10 membranes/box)
Cytoplast GBR253025mm x 30mm(4 membranes/box)
Cytoplast GBR122412mm x 24mm(10 membranes/box)
CYTOPLAST® TXT & GBR
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WOUND DRESSINGS
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BIO-XC™RESORBABLE WOUND DRESSINGS
BIO-XC™ Tape
FEATURES
• Applied directly to the wound and protect the wound and delicate new tissue
• Aids in wound healing
• Available as a plug (BIO-XC™ Plug), foam (BIO-XC™ Foam), and tape (BIO-XC™ Tape)
• Supplied sterile, non-pyrogenic and for single use only
• Essentially resorbs within 30 days of placement
Resorbable Wound Dressings are absorbent, porous, collagen matrices engineered from purified collagen derived from bovine dermis tissue.
COMMON APPLICATIONS
• Denture sores
• Oral ulcers (non-infected or viral)
• Periodontal surgical wounds
• Suture sites
• Burns
• Extraction sites
• Surgical wounds
• Traumatic wounds
BIO-XC™ Foam BIO-XC™ Plug
BIO-XCT TapeBIO-XCF FoamBIO-XCP Plug
Reference# Description
2.5cm x 7.5cm x 1mm2.0cm x 4.0cm x 3.0mm10mm x 20mm
(10 individual units per box)(10 individual units per box)(10 individual units per box)
SUTURES
Vilet™RESORBABLE SUTURES
Vilet™ is a braided coated synthetic absorbable suture made from polyglactin (PGLA) 90-10.
CHARACTERISTICS
• Maintain approximately 75-85% of its original strength at two weeks and 50-65% of its original strength at 3 weeks post implantation1
• Excellent knot security and tie down
• Superb handling—Smooth Tissue Passage
• Reliable absorption profile
• Meets or exceeds the USP & EP requirements
• Resorbs completely in 60-90 days
Vilet II Quick™RESORBABLE SUTURES
Is a fast-absorbing synthetic absorbable suture composed of a coated polyglactin (PGA).
ADDITIONAL CHARACTERISTICS
• Maintain approximately 60-70% of its original strength after 1 week post implantation1
• Completely resorbs in 42 days
1Times are based on subcutaneous tissue implantation studies in rats.
Item # Size (USP) Length Color Needle Type Needle Shape QTY/Box
VGQ386 4-0 18” Undyed C-33/8 Circle
Reverse Cut13mm
12
VGQ392 4-0 18” Undyed FS-23/8 Circle
Reverse Cut19mm
12
Item # Size (USP) Length Color Needle Type Needle Shape QTY/Box
V393 3-0 18” Violet FS-23/8 Circle
Reverse Cut19mm
12
V393U 3-0 18” Undyed FS-23/8 Circle
Reverse Cut19mm
12
V392 4-0 18” Violet FS-23/8 Circle
Reverse Cut19mm
12
V392U 4-0 18” Undyed FS-23/8 Circle
Reverse Cut19mm
12
V386U 4-0 18” Undyed C-33/8 Circle
Reverse Cut13mm
12
V385U 5-0 18” Undyed C-33/8 Circle
Reverse Cut13mm
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CytoPlast®NON-RESORBABLE SUTURES
BENEFITS
• Non-resorbable, 100% Medical Grade d-PTFE
• Monofilament construction eliminates bacterial wicking
• Biologically inert & chemically non-reactive
• Not subject to weakening by tissue enzymes
• Excellent soft tissue response
• Soft; increased patient comfort
• Great handling, knot-tying & knot-holding characteristics
COMMON APPLICATIONS
Bone grafting procedures
Guided tissue regeneration
Implant surgery
Periodontal surgery
Ridge augmentation
Soft tissue grafts
1Needle size smaller than typical FS-2 needle.
Item # Size (USP) Length Color Needle Type Needle Shape QTY/Box
CS-04 2-0 18” Undyed FS-23/8 Circle
Reverse Cut19mm
12
CS-05 3-0 18” Undyed FS-21
3/8 Circle Reverse Cut
16.3mm12
CS-051819 3-0 18” Undyed FS-23/8 Circle
Reverse Cut19mm
12
CS-06 4-0 18” Undyed FS-21
3/8 Circle Reverse Cut
16.3mm12
CS-06 PREM 4-0 18” Undyed P-33/8 Circle
Reverse Cut13mm
12
CS-06 PERIO 4-0 18” Undyed TP1/2 Circle
Taper Point13mm
12
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Direct or your local dealer for more information on product availability.
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