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PerioCare

Product catalog summary

Product Information
PerioCare is a periodontal dressing used in human health activities. It is manufactured by Pulpdent Corporation, located in Watertown, MA, USA. The product is intended for use by dental professionals only.

Hazards Identification
PerioCare is classified as non-hazardous according to both Regulation (EC) No. 1272/2008 and Directive 67/548/EEC. It is restricted to use by dental professionals.

Composition
The product consists of a paste made of metal oxides in vegetable oil and a gel containing rosins suspended in fatty acid. There are no hazardous ingredients in this formulation.

First Aid Measures
In case of eye contact, flush with water for 15 minutes. For skin contact, wash with soap and water. If inhaled, move to fresh air. The product is non-toxic if ingested.

Fire Fighting Measures
Use appropriate extinguishing media for surrounding fires. There are no special exposure hazards or protective equipment requirements.

Accidental Release Measures
Wear safety glasses, gloves, and a lab coat. Clean spills with paper towels or disposable cloths and wash the area with soap and water.

Handling and Storage
Store tightly capped in original containers at cool room temperature. The shelf life is two years from the date of manufacture if stored properly.

Exposure Controls / Personal Protection
No special equipment is required. Use surgical gloves and safety glasses. Maintain good personal hygiene.

Physical and Chemical Properties
The paste is a thick, pink substance, while the gel is a thick, yellow-tinted substance. Both have a characteristic odor and slight solubility in water.

Stability and Reactivity
The product is stable with no known conditions or materials to avoid.

Toxicological Information
PerioCare is non-toxic and may cause mild eye irritation. It has been used safely for over 30 years without reports of adverse effects.

Ecological Information
The product is not toxic to the environment.

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

Transport Information
There are no transport restrictions, and it is not regulated by IATA.

Regulatory Information
PerioCare is classified as a Class IIa medical device in the EU, a Class II medical device by the US FDA, and a Class I medical device by Health Canada.

Other Information
The 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: PerioCare 1.0 Commercial Product Name and Supplier Commercial product name / designation Periodontal dressing 851 Human health activity 55 Manufacturer Pulpdent Corporation 80 Oakland Street 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 Restricted to use by dental professional only Chemical characterization of the preparation Paste: metal oxides in vegetable oil Gel: Rosins suspended in fatty acid. Hazardous Ingredients None in this formulation General Information Non-hazardous material Material may cause mild, mechanical eye irritation. Show this safety data sheet to medical personnel. Get medical attention in case of uncertainty. Move person to fresh air. If effects occur, seek medical attention. Skin Contact Wash skin thoroughly with soap and water. Keep eyelids apart, flush with running water for 15+ minutes. Remove contact lenses after several minutes.

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Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: PerioCare 4.6 4.7 Precautions for first responders Information for physicians Symptoms Wear safety glasses and gloves. Mild, mechanical eye irritation Same as above under First Aid. Mild irritation/redness in eyes. Fire Fighting Measures Suitable extinguishing media Whatever is appropriate for surrounding fire Extinguishing media to avoid Decision should be based on surrounding fire. Special exposure hazards in a fire Special protective equipment for fire-fighters Usual protective equipment is sufficient. Accidental...

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Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: PerioCare 9.1.2 Important health, safety and environmental information Boiling point Flash point Explosive properties Oxidizing properties Vapor pressure Specific gravity Partition coefficient Vapor density Evaporation rate None known None known Hazardous decomposition products Further information Stable material Toxicological information Acute toxicity May be irritating to eyes on contact. Sub-acute, sub-chronic and prolonged toxicity None known Carcinogenicity, Mutagenicity, Reproductive Toxicity None known Empirical...

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Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: PerioCare 14.1 None. Not regulated by IATA. Regulatory Information Class IIa medical device under the MDD 93/42/EEC. Class II medical device Health Canada Class I medical device Other information List of relevant R phrases Hazard Statements Precautionary Statements Pulpdent products are for use by dental professionals only. Further information The information presented herein is believed to be factual as it has been derived from the works of persons believed to be qualified experts. However, nothing contained in this...

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