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Pulpdent Corporation
SEAL-RITE™ PIT AND FISSURE SEALANT

SEAL-RITE™ PIT AND FISSURE SEALANT

Product catalog summary

Product and Supplier Information
Seal-Rite Pit and Fissure Sealant 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 as an irritant, with potential to cause eye, skin, and respiratory irritation, as well as skin sensitization. It is restricted to use by dental professionals only.

Composition
The sealant consists of uncured acrylate ester monomers and amorphous silica, with sodium fluoride present in small quantities. These components may cause irritation and sensitization.

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 symptoms persist.

Fire Fighting Measures
Use carbon dioxide, dry chemical, alcohol foam, or water fog to extinguish fires. Avoid direct water streams. Firefighters should use self-contained breathing apparatus.

Accidental Release Measures
Ventilate the area and wear protective gear. Absorb spills with paper towels and dispose of in a covered container. Clean the area with alcohol or soap and water.

Handling and Storage
Store in a cool, shaded area, avoiding temperature extremes and direct light. The product should be used by trained dental professionals only.

Exposure Controls / Personal Protection
No special equipment is required under normal use. General ventilation is sufficient. Use standard protective gloves and safety glasses.

Physical and Chemical Properties
The product is an off-white paste with a faint odor. It has a specific gravity of 1.550 for Seal-Rite and 1.290 for Seal-Rite LV, and is insoluble in water.

Stability and Reactivity
Avoid temperature extremes and direct light. Hazardous polymerization may occur under fire conditions, releasing harmful gases.

Toxicological Information
The product is not toxic but may cause irritation and sensitization with prolonged exposure. No carcinogenic or mutagenic effects are known.

Ecological Information
Polymerized material is considered inert, with no significant ecological impact known.

Disposal Considerations
Polymerize before disposal and follow local regulations for disposal of material and packaging.

Transport Information
The product is not regulated by IATA and has no transport restrictions.

Regulatory Information
Classified as a Class IIa medical device in the EU, Class II in the US, and Class III in Canada.

Other Information
This document 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: SEAL-RITE™ PIT AND FISSURE SEALANT 1.0 Commercial Product Name and Supplier Commercial product name / designation Seal-Rite Pit and Fissure Sealant Seal-Rite Low Viscosity Pit and Fissure Sealant 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 GHS Label Elements Hazard Pictograms 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.

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Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: SEAL-RITE™ PIT AND FISSURE SEALANT 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.

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Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: SEAL-RITE™ PIT AND FISSURE SEALANT 3.0 Chemical characterization of the preparation: Hazardous ingredients CAS Number Proprietary Uncured acrylate ester monomers in a light-cured, glass-filled paste. Concentration Eye irritation, 2, H319 STOT SE 3, H335 Skin irritation, 2, H315 Skin sensitization, 1, H317 Uncured acrylate ester monomers Amorphous silica Eye irritation, 2, H319 STOT SE 3, H335 Skin irritation, 2, H315 Sodium fluoride Acute toxicity, 4 H302 Skin irritation, 2 H315 Eye irritation, 2 H319 General Information...

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Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: SEAL-RITE™ PIT AND FISSURE SEALANT Absorb/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 cap container immediately after use. Keep light-cured materials shaded from intense light sources. Store product tightly capped in original container at cool room temperature (<25OC). Avoid direct, strong light,...

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Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: SEAL-RITE™ PIT AND FISSURE SEALANT 10.0 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 that supplied in this product, hazardous polymerization may occur with heat buildup and release of carbon monoxide, carbon dioxide, oxides of nitrogen. Further information Direct light will polymerize light-cured material. Toxicological information Acute toxicity Not toxic. Minimal health...

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Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: SEAL-RITE™ PIT AND FISSURE SEALANT 16.3 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. Pulpdent products are to...

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SEAL-RITE™ PIT AND FISSURE SEALANT

SEAL-RITE™ PIT AND FISSURE SEALANT

Catalog excerpts

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