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Pulpdent Corporation
ORTHO-CHOICE™ ORTHO-COAT™

ORTHO-CHOICE™ ORTHO-COAT™

Product catalog summary

1. Product and Supplier Information
Product Name: Ortho-Choice Ortho-Coat
Manufacturer: Pulpdent Corporation, Watertown, MA, USA
Application: Dental material for professional use
Emergency Contact: 1-800-535-5053 (USA)

2. Hazards Identification
Classification: Irritant
Hazard Statements: May cause eye, skin, and respiratory irritation; potential skin sensitization
Precautionary Measures: Avoid inhalation, wear protective gear, and seek medical attention if irritation persists

3. Composition
Main Ingredients: Uncured acrylate resins (55-65%), Amorphous silica (<1%), Hydrofluoric acid (0.3%)
Hazards: Eye and skin irritation, respiratory irritation, skin sensitization

4. First Aid Measures
Inhalation: Move to fresh air, seek medical attention if needed
Skin Contact: Wash with soap and water
Eye Contact: Rinse with water for 15 minutes, seek medical attention
Ingestion: Rinse mouth, do not induce vomiting, seek immediate medical attention

5. Fire Fighting Measures
Extinguishing Media: Carbon dioxide, dry chemical, alcohol foam, water fog
Special Hazards: Heat may cause polymerization
Protective Equipment: Self-contained breathing apparatus

6. Accidental Release Measures
Personal Precautions: Ventilate area, wear safety gear
Cleanup: Absorb spill, wash area with alcohol or soap and water

7. Handling and Storage
Handling: For professional use only, avoid intense light
Storage: Store in a cool, shaded area, avoid temperature extremes

8. Exposure Controls/Personal Protection
Exposure Limits: Silica amorphous (PEL: 6 mg/m3, TLV: 10 mg/m3), Hydrofluoric acid (PEL/TLV: 3 ppm)
Protection: General ventilation, surgical gloves, safety glasses, lab coat

9. Physical and Chemical Properties
Appearance: Clear resin
Odor: Faint
Vapor Pressure: <1 mm Hg
Solubility: Nil

10. Stability and Reactivity
Conditions to Avoid: Temperature extremes, light
Hazardous Decomposition: May release carbon monoxide, carbon dioxide under fire conditions

11. Toxicological Information
Toxicity: Minimal health hazard under normal use
Irritation: Possible eye, skin, and respiratory irritation
Sensitization: Possible allergic reactions with prolonged contact

12. Ecological Information
Ecotoxicity: Polymerized material is inert

13. Disposal Considerations
Disposal: Polymerize before disposal, follow local regulations

14. Transport Information
Not regulated

15. Regulatory Information
EU: Class IIa medical device
US FDA: Class II medical device
Health Canada: Class III medical device

16. Other Information
Precautionary Statements: Avoid breathing vapor, wear protective gear
Restrictions: For dental professionals only

Catalog excerpts

Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: ORTHO-CHOICE™ ORTHO-COAT™ 1.0 Commercial Product Name and Supplier Commercial product name / designation Ortho-Choice Ortho-Coat Dental material for use by dental professional only. 851 Human health activity 55 Manufacturer Pulpdent Corporation 80 Oakland Street, P.O. Box 780 Watertown, MA 02472 USA Emergency Telephone Number 1-800-535-5053 (24 Hour / USA) Advena Limited Tower Business Centre, 2nd Floor, Tower Street, Swatar, BKR 4013 Malta Authorized European Representative Advena Limited Pure Offices, Plato Close Warwick, CV34 6WE United Kingdom MedEnvoy Switzerland Gotthardstrasse 28, 6302 Zug, Switzerland Hazards Identification Classification according to Regulation (EC) No 1272/2008 [CLP] Hazard Class Eye irritation STOT SE Skin irritation Skin sensitization Classification according to Directive 67/548/EEC (See SECTION 16 for full text of risk phrases) GHS Label Elements Hazard Pictograms Signal Word: WARNING Restricted to use by dental professional only. Hazard Statements H319: Eye irritation. 2. May cause eye irritation. H335: STOT SE. 3. May cause respiratory irritation. H315: Skin irritation. 2. May cause skin irritation. H317: Sensitization. 1. May cause an allergic skin reaction. Precautionary Statements P261: Avoid breathing vapor. P280: Wear protective gloves and eye protection P305+P351: If in eyes, rinse cautiously with water for several minutes. 1 of 5

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Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: ORTHO-CHOICE™ ORTHO-COAT™ P337+P313: If eye irritation persists, get medical advice/attention. P302+P352: If on skin, wash with plenty of soap and water. P333+P313: If irritation or rash occurs, get medical advice/attention. P410+P411: Protect from sunlight. Store at temperature not exceeding 27oC / 80oF. 3.0 Chemical characterization of the preparation: Hazardous ingredients CAS Number Proprietary Light cured, acrylate resins Concentration Eye irritation, 2, H319 STOT SE 3, H335 Skin irritation, 2, H315 Skin sensitization,...

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Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: ORTHO-CHOICE™ ORTHO-COAT™ 6.0 Accidental Release Measures Personal precautions. Ventilate area. Wear safety glasses, gloves and lab coat. Environmental precautions Contain spilled material. Follow all government regulations. Absorb or wipe up spill with paper towels or cloths. Collect for disposal in a covered container. Wash area of spill with alcohol or soap and water. For use only by dental professionals trained in its use. Follow good hygiene practices. Remove applicator tip from syringe and recap immediately...

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Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: ORTHO-CHOICE™ ORTHO-COAT™ 9.2.7 Vapor pressure Specific gravity Partition coefficient Vapor density Evaporation rate Temperature extremes (>27oC/80oF, <5oC/40oF), light. Reducing and oxidizing agents, peroxides, amines. Hazardous decomposition products Under fire conditions and with amounts far greater than in this product, hazardous polymerization may occur with heat buildup, release of carbon monoxide, carbon dioxide, oxides of nitrogen. Further information Light-cured materials polymerize when exposed to direct...

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Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: ORTHO-CHOICE™ ORTHO-COAT™ 15.3 Health Canada Class III medical device Other information List of relevant R phrases R36/37/38: Irritating to eyes, respiratory system and skin. R43: Sensitizing by skin contact Hazard Statements H319: Eye irritation. Hazard category 2. H335: Specific Target Organ Toxicity - Single exposure; hazard category. 3. Respiratory tract irritation. H315: Skin irritation. Hazard category 2. H317: Skin Sensitization. Hazard category 1. Precautionary Statements P261: Avoid breathing vapor. P280:...

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ORTHO-CHOICE™ ORTHO-COAT™

ORTHO-CHOICE™ ORTHO-COAT™

Catalog excerpts

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