SPEE-DEE™ Build-Up, Multi-Purpose Core and Tooth Build-Up Material

Product catalog summary

1. Product and Supplier Information
Trade Name: SPEE-DEE™ Build-Up, a dental material for professional use. Manufactured by Pulpdent Corporation, USA. Emergency contact available 24/7 in the USA.

2. Hazards Identification
Classified under Regulation (EC) No 1272/2008 as causing eye irritation (H319), respiratory irritation (H335), skin irritation (H315), and skin sensitization (H317). Label includes warning signal word and precautionary statements to avoid inhalation and contact with skin and eyes.

3. Composition
Contains acrylate ester monomers (55-60%) and amorphous silica (5%). Classified as irritant and sensitizing.

4. First Aid Measures
In case of inhalation, move to fresh air. For skin contact, wash with soap and water. If in eyes, rinse with water for 15 minutes. Seek medical attention if necessary.

5. Fire Fighting Measures
Use carbon dioxide, dry chemical, alcohol foam, or water fog for extinguishing. Avoid direct water streams.

6. Accidental Release Measures
Wear protective gear and contain spills. Clean with paper towels and dispose of properly.

7. Handling and Storage
Store in original container at room temperature, avoiding light and temperature extremes. Shelf life is two years if stored properly.

8. Exposure Controls/Personal Protection
No special equipment required under normal use. Use general ventilation and standard protective gear.

9. Physical and Chemical Properties
Part A is a thick yellow paste, Part B is a thick white paste. Specific gravity is 1.660, and vapor pressure is less than 1 mm Hg.

10. Stability and Reactivity
Avoid temperatures above 38°C and exposure to light. Stable under recommended storage conditions.

11. Toxicological Information
Not toxic in small quantities. May cause irritation or sensitization with prolonged exposure.

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

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

14. Transport Information
Not regulated for transport.

15. Regulatory Information
Classified as a Class II medical device in the EU and US.

16. Other Information
Revised to meet GHS SDS format and regulations. Contains hazard and precautionary statements.

Catalog excerpts

Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: SPEE-DEE™ Build-Up, Multi-Purpose Core and Tooth Build-Up Material 1.0 Commercial Product Name and Supplier Commercial product name / designation SPEE-DEE™ Build-Up Dental material for use by dental professional only. 851 Human health activity 55 Manufacturer Pulpdent Corporation 80 Oakland Street Watertown, MA 02472 USA Emergency Telephone Number Telephone: 1 617 926-6666 / Fax:1 617 926-6262 Email: [email protected] 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] Classification according to Directive 67/548/EEC 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) 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. P337+P313: If eye irritation persists, get medical advice/attention.

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SPEE-DEE™ Build-Up, Multi-Purpose Core and Tooth Build-Up Material-2

Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: SPEE-DEE™ Build-Up, Multi-Purpose Core and Tooth Build-Up Material 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 Acrylate ester monomers in two-part, glass-filled, dual-cure paste. Uncured acrylate ester monomers Eye irritation, 2, H319 STOT SE 3, H335 Skin irritation, 2, H315 Skin...

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SPEE-DEE™ Build-Up, Multi-Purpose Core and Tooth Build-Up Material-3

Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: SPEE-DEE™ Build-Up, Multi-Purpose Core and Tooth Build-Up Material 6.2 Environmental precautions Avoid releasing large amounts of uncured material into the environment. Cured / set-up material is, to our knowledge, inert. Contain spilled material. Wipe up 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. Follow good hygiene practices. Avoid direct/strong light sources, temperature extremes (>27oC/80oF,...

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SPEE-DEE™ Build-Up, Multi-Purpose Core and Tooth Build-Up Material-4

Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: SPEE-DEE™ Build-Up, Multi-Purpose Core and Tooth Build-Up Material 9.2.11 Vapor density Evaporation rate Temperature > 38oC, light, cross-contamination. 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, oxides of nitrogen. Further information Stable material if stored and used as directed. Polymerization...

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SPEE-DEE™ Build-Up, Multi-Purpose Core and Tooth Build-Up Material-5

Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: SPEE-DEE™ Build-Up, Multi-Purpose Core and Tooth Build-Up Material R43: Sensitizing by skin contact.

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SPEE-DEE™ Build-Up, Multi-Purpose Core and Tooth Build-Up Material-6

Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: SPEE-DEE™ Build-Up, Multi-Purpose Core and Tooth Build-Up Material 16.2 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: Wear protective gloves and eye protection P305 + P351: If in eyes, rinse cautiously with water for several minutes. P337 + P313: If eye...

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