: Tuff-Temp™ Plus Provisional Veneer, Crown & Bridge Resin

Product catalog summary

Product and Supplier Information
Tuff-Temp™ Plus Provisional Veneer, Crown & Bridge Resin is a dental material intended for professional use. It is manufactured by Pulpdent Corporation, located in Watertown, MA, USA. Emergency contact is available 24/7 at 1-800-535-5053.

Hazards Identification
The product is classified under Regulation (EC) No 1272/2008 as causing eye irritation (H319), respiratory irritation (H335), skin irritation (H315), and skin sensitization (H317). It is restricted to use by dental professionals only.

Composition
The resin is composed of glass-filled methacrylate resins and amorphous silica. The uncured methacrylate resins are present at 55-60% concentration and are classified as irritants.

First Aid Measures
In case of inhalation, move to fresh air and seek medical attention if necessary. For skin contact, wash thoroughly with soap and water. If in eyes, rinse with water for at least 15 minutes and seek medical attention if irritation persists. Do not induce vomiting if ingested; seek immediate medical attention.

Fire Fighting Measures
Suitable extinguishing media include carbon dioxide, dry chemical, alcohol foam, or water fog. Avoid using direct water streams. Firefighters should use self-contained breathing apparatus.

Accidental Release Measures
Wear protective equipment and avoid releasing large amounts of uncured material into the environment. Clean up spills with absorbent materials and dispose of in a covered container.

Handling and Storage
Store the product tightly capped in its original container at temperatures below 25°C. Avoid exposure to direct light and temperature extremes.

Exposure Controls/Personal Protection
No special equipment is required under normal conditions. Use surgical gloves and safety glasses for protection. Ensure good ventilation.

Physical and Chemical Properties
The product consists of two pastes with a faint characteristic odor. It has a specific gravity of 1.520 and is insoluble in water.

Stability and Reactivity
The product is stable under recommended storage conditions. Avoid exposure to temperatures above 27°C, light, and cross-contamination.

Toxicological Information
The product is not toxic in the quantities provided. It may cause irritation or sensitization upon prolonged exposure.

Ecological Information
Avoid releasing uncured material into the environment. Cured material is considered inert.

Disposal Considerations
Dispose of in accordance with local and national regulations.

Regulatory Information
The product is classified as a Class IIa medical device in the EU, Class II in the US, and Class III in Canada.

Other Information
This Safety Data Sheet has been revised to comply with GHS SDS format and relevant regulations. The information is based on expert sources but should be reviewed in the context of specific use.

Catalog excerpts

Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: Tuff-Temp™ Plus Provisional Veneer, Crown & Bridge Resin 1.0 Commercial Product Name and Supplier Commercial product name / designation Tuff-Temp™ Plus Provisional Veneer, Crown & Bridge Resin Tuff-Temp™ Provisional Add-On Tuff-Temp™ Provisional Glaze 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 Authorized European Representative 1-800-535-5053 (24 Hour / USA) Advena Limited Tower Business Centre, 2nd Floor, Tower Street, Swatar, BKR 4013 Malta 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] Classification according to Directive 67/548/EEC GHS Label Elements Hazard Pictograms Hazard Class Eye irritation STOT SE Skin irritation Skin sensitization Irritant; Xi; R 36/37/38 – 43 (See SECTION 16 for full text of risk phrases) 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. Hazard Category

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: Tuff-Temp™ Plus Provisional Veneer, Crown & Bridge Resin-2

Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: Tuff-Temp™ Plus Provisional Veneer, Crown & Bridge Resin 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. 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...

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: Tuff-Temp™ Plus Provisional Veneer, Crown & Bridge Resin-3

Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: Tuff-Temp™ Plus Provisional Veneer, Crown & Bridge Resin 5.3 Special exposure hazards in a fire Heat may cause polymerization with rapid release of energy. Special protective equipment for fire-fighters Self-contained breathing apparatus Accidental Release Measures Personal precautions. Wear safety glasses, gloves and lab coat. Environmental precautions Avoid releasing large amounts of uncured material into the environment Cured / set-up material is, to our knowledge, inert. Contain spilled material. Absorb or wipe...

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: Tuff-Temp™ Plus Provisional Veneer, Crown & Bridge Resin-4

Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: Tuff-Temp™ Plus Provisional Veneer, Crown & Bridge Resin 9.2.6 Oxidizing properties Vapor pressure Specific gravity Partition coefficient Vapor density Evaporation rate Temperature > 27oC / 80oF, light, cross-contamination of parts. Reducing and oxidizing agents, peroxides, amines. Hazardous decomposition products Under fire conditions and with amounts greater than that supplied in this product, hazardous polymerization may occur with heat build-up and release of carbon monoxide, carbon dioxide, and oxides of nitrogen....

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: Tuff-Temp™ Plus Provisional Veneer, Crown & Bridge Resin-5

Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: Tuff-Temp™ Plus Provisional Veneer, Crown & Bridge Resin 14.1 Regulatory Information Class IIa medical device under MDD 93/42/EEC Class II medical device. 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....

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