TECHNICAL MANUAL

Rev. 4/23/08

Copyright © 2008 Dentsply International

Calm-it™ Desensitizer Technical Manual

Introduction Acute postoperative sensitivity can appear in response to temperature fluctuations, to percussion, or to masticatory forces, and may also occur without stimulus. The hypersensitivity may last as little as a few hours or as long as weeks or months after restoration placement, and generally occurs in the absence of pathology such as caries. While the frequency of occurrence of sensitivity may be low, its effects on the patient and the highly variable time frame over which it resolves itself make it a particularly troublesome source of complaints for the practitioner. Over the years this phenomenon has been studied extensively to determine its origins, and develop methods and materials to prevent or eliminate it. The sensitivity has been attributed largely to fluid flow into and out of open dentinal tubules that can stimulate the pulpal tissue as a response to thermal fluctuations, percussive forces, and occlusal stresses1-8. This hydrodynamic theory is supported by observations with total etch restorative techniques that tend to open the tubules and with deeper restorations where tubules are wider, more numerous, and nearer the pulpal chamber, that are more likely to lead to sensitivity than their more conservative alternatives. Along with the hydrodynamic theory, studies have also pointed to approaches that can reduce the likelihood of developing postoperative sensitivity. The two primary approaches arising from this work are to8:

• Occlude the tubules to prevent fluid flow and the resulting pulpal stimulation;

• Anesthetize the pulpal tissue so that even if the fluid flow occurs, no pulpal stimulus takes place.

Bacterial activity may also cause irritation of the dental pulp and therefore pain. According to this theory, the bacteria are not eliminated from the restoration site during the restoration procedure. A resulting approach to reducing or eliminating the sensitivity is to apply a disinfectant to kill bacteria at the restoration site.

Over a number of years, these approaches have led to a variety of products for use during the restorative process to reduce the occurrence of sensitivity. Some examples are described below:

• Self-etching adhesives such as Xeno III and Xeno IV provide a strong dentinal bond and at the same time allow the smear layer to remain in place. This enables the debris from instrumentation that makes up the smear layer to act as an

occluding agent in the tubules. This provides a mechanism to prevent fluid flow and resulting hypersensitivity.

• Desensitizers containing anesthetics such as potassium nitrate can be placed under restoratives, thereby providing extended relief from pulpal stimulus. This relief can last until the fluid flow would no longer stimulate the pulpal tissue.

• Desensitizers containing antibacterial agents can be used to disinfect the cavity surfaces prior to restoration material placements. Examples of these antibacterial agents are chlorhexidine and benzalkonium chloride.

• Products that actively occlude the tubules are the most commonly used. Such materials include bioglass, a simple barrier that also elutes calcium ions as an acid buffer, and glutaraldehyde, which crosslinks proteins in the dentinal fluid to create a barrier deep into the tubules. Further, standard dentinal adhesives with their long resin tags can provide tubular occlusion and thereby prevent sensitivity. In some cases the adhesives are not sufficient by themselves to do so, hence there is need for an additional desensitizer prior to the application of the adhesive.

Calm-it™ Desensitizer

Calm-it™ Desensitizer is based on aqueous glutaraldehyde, which occludes the tubules by crosslinking the dentinal proteins. It also contains hydroxyethyl methacrylate (HEMA) as a primer, or wetting agent, in order to help carry the glutaraldehyde deep into the tubules.

Tubule Occlusion: When using the total-etch bonding technique, the clinician often etches the instrumented dentin to open the tubules so that extensive adhesive resin tags can form. Prior to placing the adhesive, however, the dentin is coated with Calm-it™ Desensitizer. This immediately occludes the tubules deep into the dentin, as can be seen in Figure 1. Here, the etched but untreated dentin is shown on the left, and the etched and treated dentin is shown on the right. Clearly, the tubules in the untreated dentin are open while those in the treated dentin are occluded.

Figure 1: Prepared, etched dentin (left), and prepared, etched dentin with Calm-it™ Desensitizer (right).

Bond Strength: Once the desensitizer is placed the adhesive is then applied to the prep. This should be done without rinsing so that the HEMA primer remains on the dentin. The HEMA promotes thorough penetration of the adhesive into the dentinal tubules and around the crosslinked dentinal proteins, and becomes incorporated into the adhesive with its methacrylate functionality. As a result the bond strength of the adhesive is maintained even though the resin tags formed may be shorter than those without the desensitizer.

In order to show that the bond strength of the adhesive is not compromised by Calm-it™ Desensitizer, shear bond strength was measured on the complete line of Dentsply bonding agents.

Freshly extracted human molars were cut and ground to expose flat dentin surfaces with abrasive papers. For total etch adhesives, the dentinal surfaces were acid etched for 15 seconds with phosphoric acid gel, rinsed with water, and blot dried. When placing self-etch adhesives the dentin surfaces were not acid etched. The samples were prepared as follows:

• In the control group, five Dentsply adhesives (ProBond, Prime & Bond NT, XP Bond, Xeno III, and Xeno IV) were applied and cured following their respective DFUs. Then composite posts were attached (straw filled with TPH3) to the adhesive and cured with a halogen curing unit for 3x20 seconds at 550 mW/cm2.

• In the test group the same procedure was followed except that prior to placement of the adhesives Calm-it™ Desensitizer was applied using a gentle rubbing motion for 30-60 seconds, and was gently blotted without rinsing.

After the samples were prepared they were stored in deionized water at 37C for 24 hours. Standard shear bond strength testing was performed on an Instron mechanical tester using a crosshead speed of 1 mm/min. The results of this testing are shown in Table 1.

Based on the results shown here, there is no statistically significant difference between the Calm-it™ treated and untreated shear bond strength for any of the bonding agents tested.

Desensitizer (Lot #)

Xeno III Xeno IV Prime & Bond NT

ProBond XP Bond

Control (no desensitizer used)

13.9 ± 2.7

20.1 ± 3.0

16.8 ± 2.6

16.2 ± 2.1

15.0 ± 1.6

With Calm-it™ (081007)

14.0 ± 3.0

20.6 ± 2.5

17.1 ± 1.6

16.0 ± 3.8

18.3 ± 4.8

Table 1: Shear Bond Strength of TPH3 straw-post bonded to human dentin (light cured).

Compatibility with Restorative Materials: Another important characteristic of any desensitizer is that it be compatible with contemporary restorative materials such as amalgam, restorative composites, and luting cements.

Amalgam

To evaluate the impact of Calm-it™ on the setting properties of amalgam, Dentsply’s Dispersalloy was triturated according to its DFU and placed in 4mm diameter x 8mm deep cylindrical molds, which were then immediately placed into the following storage media: air, deionized water, and Calm-it™ Desensitizer. The tightly capped containers were then placed into a 37C oven for 24 hours. Finally, the samples were tested for compressive strength using an Instron Mechanical Tester at 0.25 mm/min crosshead speed.

The results of this testing protocol are shown in Table 2. There was no statistically significant difference between treatments.

Setting & Storage Media (37C for 24 hours)

Air

DI Water

Calm-it™

Compressive Strength (MPa) 439 ± 16 430 ± 21 433 ± 11

Compressive Strength (PSI) 63630 ± 2357 62383 ± 3111 62733 ± 1641

Table 2: Effect of Calm-it™ Desensitizer on the 24-hour Compressive Strength of Dispersalloy

Core Buildup Material

To evaluate the compatibility of Calm-it™ Desensitizer with core buildup materials, Dentsply’s Fluorocore II was tested. Here, the control group consisted of preparing recently extracted molars by exposing dentin with abrasive paper on a lap bench, applying Xeno IV adhesive (Self-cure, with Self-Cure Activator), and attaching Fluorocore II posts onto the adhesive. All posts were allowed to self-cure for 15 minutes at room temperature. The test group was prepared identically except that Calm-it™ Desensitizer was applied to the exposed dentin just prior to the application of the bonding agent. The samples were stored in deionized water at 37C for 24 hours prior to mechanical testing. Shear bond strengths of the samples were measured as described in the Bond Strength section above.

There was no significant difference between the system treated with Calm-it™ Desensitizer and the one without it, as shown in Table 3.

Test Condition (MPa)

Control (No desensitizer used)

11.8 ± 3.5

With Calm-it™ (Apply prior to adhesive)

20.1 ± 4.8

Table 3: Shear bond strength of Fluorocore II straw posts bonded to human dentin (self-cure only; bonded with self-cured adhesive)

Resin Cement

To evaluate the compatibility of Calm-it™ Desensitizer with resin cement, Calibra Esthetic Resin Cement was tested. Here, the control group consisted of preparing recently extracted molars by exposing dentin with abrasive paper on a lap bench and applying either XP Bond adhesive (Self-cure, with Self-Cure Activator) or Prime & Bond NT (Light cure). Calibra posts were placed on each adhesive and either self-cured (XP Bond) or light cured (Prime & Bond NT). The samples were stored in deionized water at 37C for 24 hours prior to mechanical testing. Shear bond strengths of the samples were measured as described in the Bond Strength section above.

There was no statistically significant difference between the systems treated with Calm-it™ Desensitizer and the ones without it, as shown in Table 4.

Test Condition Self-Cure (XP Bond adhesive)

Light-Cure (Prime & Bond NT

adhesive)

Control (MPa) (No desensitizer used)

18.8 ± 3.8

10.5 ± 3.3

With Calm-it™ (MPa) (Apply prior to adhesive)

15.7 ± 4.0

14.1 ± 5.5

Table 4: Shear bond strength of Calibra straw posts bonded to human dentin in both self-cure and light cure modes.

Temporary Cement

For the effect of Calm-it™ Desensitizer on the setting behavior of Integrity TempGrip temporary cement, the setting process was examined on a TA Instruments AR1000 Rheometer with a 2-cm diameter flat plate and a gap distance of 2mm. Calm-it™ Desensitizer was dispensed onto the rheometer stage before loading of the cement onto the stage, and the storage and loss moduli measured in oscillatory mode as a function of time. The control was run identically except for the absence of Calm-it™ Desensitizer.

Results of this testing are shown in Figure 2. There is little difference in the setting behavior of Integrity TempGrip cement with and without Calm-it™ Desensitizer.

With this extensive in vitro testing of the compatibility of Calm-it™ Desensitizer with adhesives, core build-up material, resin cement, amalgam, and temporary cement, it may be concluded that Calm-it™ Desensitizer is compatible with the broad variety of restorative materials used in contemporary dentistry.

1.0E+04

1.0E+05

1.0E+06

1.0E+07

9 22 40 58 76 94 113

131

149

167

185

203

221

239

257

275

293

Time (s)

G' S

tora

ge M

odul

us (P

a)

1.0E+04

1.0E+05

1.0E+06

1.0E+07

G''

Loss

Mod

ulus

(Pa)

w/ Calm-It G' w/ Calm-It G''w/o Calm-It G' w/o Calm-It G''

Figure 2: Effect of Calm-it™ Desensitizer on the setting behavior of Integrity TempGrip temporary cement.

Acceptable pH: A desirable characteristic of a dentin desensitizer is that it should not be excessively acidic. This is to ensure that the integrity of the mineral portion of the dentin is not compromised. Our view is that an acceptable pH range is 3.2 – 4.4.

The pH of Calm-it™ Desensitizer was measured on an Accumet AR50 pH meter. Buffer standards at 2.00, 4.00, and 7.00 were used to calibrate the meter. All samples were conditioned to 23C (room temperature) prior to testing. Calm-it™ Desensitizer was compared to Gluma Desensitizer (Heraeus Kulzer) and MicroPrime G Desensitizer (Danville Materials).

The results of pH testing are shown in Table 5. The pH of Calm-it™ Desensitizer is approximately 3.8, within the desirable range. Further, this pH is similar to the pH of the comparison materials tested.

Desensitizer Manufacturer pH1 pH2 pH3 Mean StDev

Calm-it™ Dentsply 3.76 3.81 3.81 3.79 0.03

Gluma Heraeus Kulzer

3.60 3.59 3.59 3.59 0.01

MicroPrime G Danville Materials

3.49 3.48 3.48 3.48 0.01

Table 5: pH measurement of Calm-it™ Desensitizer and similar desensitizers at 23C.

Viscosity: Yet another characteristic important to the performance of a dentin desensitizer is viscosity. In order for the material to penetrate deeply into the dentinal tubules, its viscosity must be similar to that of water. An acceptable range is 2-4 cps.

The viscosity of Calm-it™ Desensitizer was measured at 25C on a TA Instruments AR1000 Rheometer. A 2-degree, 4cm diameter cone plate was used for this low-viscosity solution. The results of the testing are shown in Table 6 compared to other available dentin desensitizers.

The viscosity of Calm-it™ Desensitizer was approximately 2.75 cps, well within the acceptable range and comparable to the viscosities of similar products.

Desensitizer

Manufacturer

Mean η (cps)

StDev η (cps)

Calm-it™ Dentsply 2.75 0.10

Gluma Heraeus Kulzer 2.95 0.07

MicroPrime G Danville Materials 2.85 0.10

Desensitizer G Health-Dent 2.65 0.001

Table 6: Viscosity of Calm-it™ Desensitizer and comparable materials at 25C.

Directions for Use

Calm-it™

Desensitizer 0120 DIRECTIONS FOR USE – ENGLISH For dental use only. USA: Rx only. 1. PRODUCT DESCRIPTION Calm-it™ Desensitizer is a liquid designed to treat and prevent dentinal hypersensitivity. It is designed to reduce/eliminate hypersensitivity in exposed dentin tubules in cervical areas. It can also be used under either indirect restorations (veneers, crowns, inlays, onlays), or direct restorations (amalgams, composites). Calm-it™ Desensitizer functions by reacting/crosslinking with the proteins in the dentinal fluid to form a physiological seal within the tubules. Dentin hypersensitivity due to hydrodynamic changes can be greatly reduced/eliminated as the intra-tubular fluid movements have been substantially suppressed. 1.1 Delivery forms Calm-it™ Desensitizer is available in: • 6ml Bottle • .125ml Unit Dose delivery system 1.2 Composition Glutaraldehyde; HEMA; DI Water 1.3 Indications Calm-it™ Desensitizer is indicated for treating and preventing dentinal hypersensitivity. The agent can be used under direct restorations, under indirect restorations, and on cervical sensitivity. 1.4 Contraindications 1. Calm-it™ Desensitizer is contraindicated for use with patients who have a history of severe allergic reaction to methacrylate resins or any of the components. 2. Calm-it™ Desensitizer is contraindicated for direct application to dental pulp tissue (direct pulp capping). 2. GENERAL SAFETY NOTES Be aware of the following general safety notes and the special safety notes in other chapters of these directions for use.

2.1 Warnings 1. Calm-it™ Desensitizer contains polymerizable methacrylates which may be

irritating to skin, eyes and oral mucosa and may cause allergic contact dermatitis in susceptible persons.

2. Calm-it™ Desensitizer contains glutaraldehyde which may be irritating to skin, eyes and oral mucosa and may cause allergic contact dermatitis in susceptible persons.

3. Avoid eye contact to prevent irritation and possible corneal damage. In case of contact with eyes, rinse immediately with plenty of water and seek medical attention.

4. Avoid skin contact to prevent irritation and possible allergic response. If contact with skin occurs, immediately remove material with cotton and wash thoroughly with water and soap. In case of skin sensitisation or rash, discontinue use and seek medical attention.

5. Avoid contact with oral soft tissues/mucosa to prevent inflammation. If accidental contact occurs, immediately remove material from the tissues. Flush mucosa with plenty of water after the restoration is completed and expectorate/evacuate the water. If sensitisation of mucosa persists, seek medical attention.

2.2 Precautions 1. This product is intended to be used only as specifically outlined in the

Directions for Use. Any use of this product inconsistent with the Directions for Use is at the discretion and sole responsibility of the practitioner.

2. Wear suitable protective eyewear, clothing and gloves. Protective eyewear is recommended for patients.

3. Contact with saliva, blood and/or some astringent solutions during adhesive procedures may cause failure of the restoration. Use of a rubber dam or adequate isolation is recommended.

4. Application of phosphoric acid following application of Calm-it™ Desensitizer may remove applied desensitizer and/or reduce desensitizer efficacy.

2.3 Storage conditions Calm-it™ Desensitizer should be kept out of direct sunlight and stored in a well ventilated place at room temperature not exceeding 25ºC/77ºF (10-25ºC/50-77ºF). Refrigerated storage is not required, but is acceptable when not in use. Allow material to reach room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date. 2.4 Adverse reactions Product may irritate the eyes and skin. Eye contact: irritation and possible corneal damage. Skin contact: irritation or possible allergic response. Mucous membranes: inflammation. (See Warnings)

3. STEP-BY-STEP INSTRUCTIONS 3.1 Calm-it™ Desensitizer under direct restorations 3.1.1 Cleaning: Clean uninstrumented dentin with a rubber cup and pumice or a

cleaning paste such as Nupro® Prophylaxis Paste. Wash thoroughly with water spray and air dry. Clean freshly instrumented enamel and dentin with water spray and then air dry. Apply a rubber dam or other suitable isolation technique.

3.1.2 Pulp Protection: For direct and indirect pulp capping, cover the dentin close to the pulp (less than 1mm) with a hard setting calcium hydroxide liner (Dycal® Liner) leaving the rest of the cavity surface free for bonding with selective adhesive.

3.1.3 If using a total etch adhesive system, apply the tooth conditioner to the tooth surface using the total etch technique described in manufacturer’s Directions for use. Do not apply the adhesive. Proceed to steps 3.1.5- 3.1.9. NOTE: If using a total etch adhesive system, etching of the tooth surface must be completed prior to the use of Calm-it™ Desensitizer.

3.1.4 If using a self etch adhesive system, do not apply adhesive at this stage. Proceed to steps 3.1.5-3.1.9.

3.1.5 Unit Dose Container: Grasp Calm-it™ Desensitizer unit dose, placing between thumb and index finger on the lower brush handle and black unit dose base and firmly apply pressure until the vial snaps open. Bend in the other direction to separate the brush. The unit dose can then be placed into the blue holder. Alternatively, insert the base of the Calm-it™ Desensitizer unit dose in the blue holder, hold the base steady with one hand and grasp the handle near the bottom with the other hand. Then bend the handle to snap open the vial, and bend it in the opposite direction to separate the brush. Conventional Bottle: Shake Calm-it™ Desensitizer bottle well. Dispense the appropriate amount of Calm-it™ Desensitizer into a clean dappen dish or mixing well. Replace cap promptly.

3.1.6 Immediately apply Calm-it™ Desensitizer to dentin for 30-60 seconds, using a gentle rubbing motion. The dentin should remain damp. Do not over-apply and avoid the contact of soft tissue. NOTE: Any Calm-it™ Desensitizer in contact with enamel will not adversely affect adhesive bond.

3.1.7 Remove excess by gently drying with clean, dry air from a dental syringe. Do not rinse or completely dry the surface. Recommended technique is to begin drying/evaporation with the syringe approximately 4-6 inches (10-15cm) away from the surface, gradually bringing the source to within 0.5 inches (10mm) of the surface over 5-10 seconds.

3.1.8 Immediately apply adhesive as described in manufacturer’s Directions for use. DO NOT RE-ETCH IF USING A TOTAL ETCH ADHESIVE SYSTEM!

3.1.9 Place the restorative material over the cured adhesive as per manufacturer’s Directions for Use.

3.2 Calm-it™ Desensitizer under indirect restorations 3.2.1Temporary Seating

3.2.1.1 Following tooth preparation, core build-up and fabrication of the provisional restoration, clean enamel and dentin with water spray and then air dry. Apply a rubber dam or other suitable isolation technique.

3.2.1.2 Prepare unit dose container or shake bottle and dispense material Into dappen dish or mixing well as outlined in 3.1.5 above. NOTE: When used as a desensitizer under temporary restorations, without adhesive, etching of dentin is not necessary.

3.2.1.3 Apply Calm-it™ Desensitizer to dentin for 30-60 seconds, using a Gentle rubbing motion. Do not over-apply and avoid the contact of soft tissue.

3.2.1.4 Remove excess by gently drying with clean, dry air from a dental syringe. Do not completely dry the surface. Recommended technique is to begin drying/evaporation with the syringe approximately 4-6 inches (10-15cm) away from the surface, gradually bringing the source to within 0.5 inches (10mm) of the surface over 5-10 seconds.

3.2.1.5 Proceed with seating temporary/provisional restoration with Temporary cement per manufacturer’s instructions.

3.2.2Final Seating 3.2.2.1 Following removal of the temporary restoration and any remaining

temporary cement, clean enamel and dentin with a rubber cup and pumice or a cleaning paste such as Nupro® Prophylaxis Paste then as directed by the selected adhesive manufacturer’s directions. NOTE: If using a total etch adhesive system, etching of the tooth surface must be completed prior to the use of Calm-it™ Desensitizer.

3.2.2.2 If using a total etch adhesive system, apply the tooth conditioner to the tooth surface using the total etch technique described in manufacturer’s Directions for use. Do not apply the adhesive. Proceed to steps 3.2.2.4-3.2.2.8.

3.2.2.3 If using a self etch adhesive system, do not apply adhesive at this stage. Proceed to steps 3.2.2.4-3.2.2.8.

3.2.2.4 Prepare unit dose container or shake bottle and dispense material Into dappen dish or mixing well as outlined in 3.1.5 above.

3.2.2.5 Immediately apply Calm-it™ Desensitizer to dentin for 30-60 seconds, using a gentle rubbing motion. The dentin should remain damp. Do not over-apply and avoid the contact of soft tissue.

3.2.2.6 Remove excess by gently drying with clean, dry air from a dental syringe. Do not rinse or completely dry the surface. Recommended technique is to begin drying/evaporation with the syringe approximately 4-6 inches (10-15cm) away from the surface,

gradually bringing the source to within 0.5 inches (10mm) of the surface over 5-10 seconds.

3.2.2.7 Immediately apply adhesive as described in manufacturer’s Directions for use. DO NOT RE-ETCH IF USING A TOTAL ETCH ADHESIVE SYSTEM!

3.2.2.8 Proceed with cementation of restoration per manufacturer’s instructions.

3.3 Treatment of cervical sensitivity 3.3.1 Cleaning: Clean uninstrumented enamel and dentin with a rubber cup and

Pumice or a cleaning paste such as Nupro® Prophylaxis Paste. Wash thoroughly with water spray and blot dry. For best results, saturate a cotton pellet and remove excess water from the pellet by blotting it on a gauze pad before using the pellet to blot the tooth.

3.3.2 Protect mucous membranes by using a rubber dam; Make sure that Calm-it™ Desensitizer only comes into contact with the tooth structure to be treated.

3.3.3 Prepare unit dose container or shake bottle and dispense material into dappen dish or mixing well as outlined in 3.1.5 above. NOTE: When used as a desensitizer without subsequent adhesive/restoration, etching of dentin is not necessary.

3.3.4 Apply Calm-it™ Desensitizer to dentin for 30-60 seconds, using a gentle rubbing motion. Do not over-apply and avoid the contact of soft tissue.

3.3.5 Remove excess by gently drying with clean, dry air from a dental syringe. Do not completely dry the surface. Recommended technique is to begin drying/evaporation with the syringe approximately 4-6 inches (10-15cm) away from the surface, gradually bringing the source to within 0.5 inches (10mm) of the surface over 5-10 seconds. Technique Tip: The effect of Calm-it™ Desensitizer can be tested any time during this protection by applying a short blast of air to the treated area.

3.3.6 This treatment can be repeated if a single application does not generate sufficient desensitizing effect.

3.3.7 In extreme cases where severe cervical sensitivity is a continuous problem, alternative treatments may be indicated.

4. HYGIENE 4.1 Cleaning and disinfection To prevent Calm-it™ Desensitizer bottle from exposure to spatter or spray of body fluids or contaminated hands, or oral tissues, use of a protective barrier is recommended to avoid package contamination. Repeated disinfection may damage label. Do not attempt to clean, disinfect or re-use applicator brush or unit dose container. Properly dispose of used brushes and containers.

5. LOT NUMBER AND EXPIRATION DATE 1. Do not use after expiration date. ISO standard is used: “YYYY/MM” 2. The following numbers should be quoted in all correspondence: • Reorder Number • Lot number ©2008 DENTSPLY International. All rights reserved. Printed in U.S.A. Manufactured by: DENTSPLY Caulk 38 West Clarke Avenue Milford, DE 19963 USA Tel.: 1-302-422-4511 DENTSPLY Canada 161 Vinyl Court Woodbridge, Ontario L4L 4A3 Canada

Form #51A000 (1/11/08)

MSDS

DENTSPLY/International DENTSPLY/Caulk

Material Safety Data Sheet 51A898

1. Product and Company Identification Product Name Calm-it™

MSDS Code Number 51A898

Trade Name & Synonyms Calm-it Dentin Desensitizer Solution

Date of Last Revision 12/03/07

Chemical Name Desensitizer

Manufacturer DENTSPLY/Caulk

C.A.S. Number Not Applicable

Address 38 West Clarke Avenue Milford DE 19963-1805 http://www.caulk.com

Grades or Minor Variant Identities Not Applicable

Information Telephone Number (302) 422-4511 (8:00 AM – 4:30 PM Eastern Time)

Product Use (for Canada) Dentin Desensitizer

Emergency Telephone Number (302) 422-4511 (8:00 AM – 4:30 PM Eastern Time)

2. Composition Of Ingredients Hazardous Components C.A.S. Number Exposure Limits % 2-Hydroxyethyl methacrylate 868-77-9 N.E. < than 45 Glutaraldehyde 111-30-8 0.05 ppm < than 10

3. Hazard Identification Emergency Overview Material is irritating to eyes, respiratory system and skin.

Routes of Exposure

Signs and Symptoms

Single, Repeated, or Lifetime Exposure

Severity (Mild, Moderate, Severe)

Acute and Chronic Health Effect(s) Target Organ(s)

Eye Material can cause irritation.

Single Moderate Irritation and possible corneal damage Not Applicable

Skin Material may cause sensitization

Single & Repeated Moderate Irritation or possible allergic response. Severe allergic response may result

in breathing difficulties.

Not Applicable

Inhalation Material maybe harmful if inhaled

Single & Repeated Mild May cause chemical burns to the respiratory tract

Not Applicable

Ingestion Material harmful if swallowed

Single & Repeated Moderate Potential gastrointestinal tract burns Not Applicable

Other Not Applicable Not Applicable Not Applicable Not Applicable Not Applicable Medical Conditions Aggravated by Exposure Open sores and wounds of the skin. Individuals with known sensitivity to methacrylates, acrylates, or urethane dimethacrylate resin used in Dental restorative products. Carcinogenicity NTP?: Not listed IARC monographs?: Not listed OSHA regulated?: No All components of this product are in compliance with the inventory listing Requirements of the U. S. Toxic Substances Control Act (TSCA) Chemical Substance Inventory. Potential Environmental Effects Do not allow to enter sewers/ surface or ground water. NFPA Hazard Classification Ratings (Scale 0-4), Health = 1, Fire = 0, Reactivity = 0

DENTSPLY/International DENTSPLY/Caulk

Material Safety Data Sheet

5. Fire and Explosion Data

Flashpoint Method: Not Applicable

Flammable (Explosive) Limits in Air LEL: Not Applicable UEL: Not Applicable

Autoignition Temperature: Not Applicable. Product will not autoignite.

Flame Propagation or Burning Rate (for Solids): Not Applicable

Properties Contributing to Fire Intensity: Not Applicable

Flammability Classification: Not Applicable

Other: Not Applicable

Extinguishing Media: CO2, extinguishing powder, foam carbon dioxide or water spray. Fight larger fires with water spray or alcohol resistant foam.

Extinguishing Media to Avoid: Water with full jet.

Protection and Procedures for Firefighters: Firefighters should wear self-contained respiratory protective devices. Unusual Fire and Explosion Hazards: Formation of toxic, irritating gases is possible from the decomposition of the dimethacrylate resins. Product does not present an explosion hazard.

6. Accidental Release Measures

Containment Techniques: Absorb with liquid –binding material, (sand, diatomaceous earth, universal binders, sawdust). Spill/Leak Clean-up Procedures and Equipment: Wear protective clothing and scoop up bulk material and place in a labeled plastic or metal container. Avoid gross skin contact to minimize the possibility of contact dermatitis to susceptible persons. Ensure adequate ventilation. Evacuation Procedures: Not Applicable Special Instructions: Not Applicable Reporting Requirements: Not Applicable

7. Handling and Storage

Handling Practices and Warnings: Product is intended for dental use only. Handling of this product should be by trained dental healthcare professionals only. Observe normal care for working with chemicals. Storage Practices and Warnings: Store only in the original package. Keep package tightly sealed. Store in a dry area. Protect from exposure to direct light. Store away from food and beverages.

8. Exposure Control / Personal Protection

Ventilation: Ensure good ventilation at the workplace. Other Engineering Controls: N. A. Routes of Entry Personal Protective Equipment (PPE) for Normal Use PPE for Emergencies Eye/Face Safety Glasses Not Applicable Skin The glove material has to be impermeable and resistant to the product. Not Applicable Inhalation Not Required Not Applicable Body Protection Protective work clothing Not Applicable General Hygiene Considerations and Work Practices: Keep away from foodstuffs, beverages and feed. Immediately remove all soiled and contaminated clothing. Wash hands before breaks and at end of work. Avoid contact with the eyes and skin. Protective Measures During Repair and Maintenance of Contaminated Equipment: Not Applicable Other Protective Measures and Equipment: Not Applicable ACGIH TLV: Glutaraldehyde (CAS 111-30-8), STEL = 0.05 ppm

9. Physical and Chemical Characteristics

Appearance: Colorless liquid Odor: Slight fruity odor Normal Physical State: Liquid Melting Point: Not Applicable Specific Gravity: 1.04 g/cm3 Solubility in Water: miscible with water pH: 3.8 at 22°C Vapor Pressure (mm Hg): Not Applicable Vapor Density (AIR=1): Not Applicable Evaporation Rate (Butyl Acetate =1): Not Applicable Other: Not Applicable

4. First Aid Measures Routes of Exposure First Aid Instructions Immediate Medical Attention Delayed Effects Eye Rinse opened eye for several minutes under running water. If

symptoms persist consult physician Not Applicable Not Applicable

Skin Immediately wash with soap and water and rinse thoroughly Not Applicable Not Applicable Inhalation Supply fresh air, consult physician if symptoms persist Not Applicable Not Applicable Ingestion Consult physician immediately Not Applicable Not Applicable Other Not Applicable Not Applicable Not Applicable Note to Physicians (Treating, Testing and Monitoring): Treat symptomatically.

DENTSPLY/International DENTSPLY/Caulk

Material Safety Data Sheet

10. Stability and Reactivity Data Incompatibility (Materials to Avoid): Strong oxidizing agents, strong bases Hazardous Products Produced During Decomposition: No dangerous decomposition products known if used according to Directions for Use. Hazardous Polymerization: May Occur May Not Occur Conditions to Avoid: Extreme prolonged heat Stability? Stable Unstable Conditions to Avoid: Extreme prolonged heat

11.Toxicological Information

Toxicity Data, Epidemiology Studies, Carcinogenicity, Neurological Effects, Genetic Effects, Reproductive Effects, or Structure Activity Data: Product is an irritant to the skin and mucous membranes. On the eye the product has an irritating effect. Sensitization: Repeated or prolonged skin contact or inhalation may cause sensitization for persons allergic to methacrylates and aldehydes. This product shows the following dangers according to internally approved calculation methods for composite materials: Irritant.

12.Ecological Information

Toxicity Data, Environmental Fate, Physical/Chemical Data, or other Data Supporting Environmental Hazard Statements: Water Hazard class1 (Self-assessment): slightly hazardous for water. Do not allow undiluted product or large quantities of it to reach ground water, water streams or sewage system.

13.Disposal Considerations

Regulations: Must not be disposed of together with household garbage. Do not allow product to reach sewage system. Dispose of material as solid waste in a closed container. Dispose of in accordance with Federal, State and Local regulations Properties (Physical/Chemical) Affecting Disposal: Dispose of material as solid waste in a closed container.

14.Transport Information

Regulated for Shipping: No. Not Regulated DOT Shipping Name: Not Regulated Packing Group: Not Applicable Do Changes in Quantities, packaging, or shipment method change product classification? No

DOT Hazard Class: Not Applicable UN Number: Not Applicable

15.Regulatory Information

U.S. Federal Regulations: CERCLA 103 Reportable Quantity: This product is not subject to CERCLA reporting requirements. Many states have more stringent release reporting requirements. Report spills required under federal, state and local regulations Section 313 Toxic Chemicals: This product contains the following chemicals subject to Annual Release Reporting Requirements Under SARA Title III, Section 313 (40 CFR 372): None Section 302 Extremely Hazardous Substances (TPQ): None EPA Toxic Substances Control Act (TSCA) Status: All of the components of this product are listed on the TSCA inventory. U.S. State Regulations California Proposition 65: This product does not contain any chemicals, which are on the California Proposition 65 list. International Regulations: Canadian Environmental Protection Act: This product is a medical device and not subject to chemical notification requirements. European Community Labeling: Not a dangerous preparation. European Inventory of New and Existing Chemicals Substances (EINECS): This product is a medical device and not subject to chemical notification requirements. Other: Not Applicable

16.Other Information

To the best of our knowledge this product does not contain gluten, wheat grains, flaxseed, natural rubber, or natural latex. All components are synthetically produced; none are derived from animal products.

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Rev. 4/22/08