PULPDENT Orthodontic Bracket Adhesive (OBA) and Ortho-Choice™ OBA Bonding Resin

Product catalog summary

Product and Supplier Information
Trade Name: PULPDENT Orthodontic Bracket Adhesive (OBA) and Ortho-Choice™ OBA Bonding Resin. Manufactured by Pulpdent Corporation, USA. For dental professional use only.

Hazards Identification
Classified as an irritant. May cause eye, skin, and respiratory irritation, and skin sensitization. GHS Label Elements include hazard statements such as H319 (eye irritation), H335 (respiratory irritation), H315 (skin irritation), and H317 (skin sensitization).

Composition
Contains glass filler in light-cured methacrylate resins and amorphous silica. Hazardous ingredients include methacrylate ester monomers and amorphous silica.

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

Fire Fighting Measures
Use carbon dioxide, dry chemical, alcohol foam, or water fog for extinguishing. Avoid direct water stream. Fire may cause polymerization with rapid energy release.

Accidental Release Measures
Ventilate area and wear protective gear. Contain and clean up spills with paper towels or cloths. Dispose of in a covered container.

Handling and Storage
Store in original containers at cool room temperature, away from light and ignition sources. Shelf life is two years if stored properly.

Exposure Controls / Personal Protection
Use protective gloves and safety glasses. Ensure good ventilation. Emergency eye wash should be available.

Physical and Chemical Properties
OBA is a stiff off-white paste; OBA Resin is a yellow oily liquid. Characteristic resin odor. Not soluble in water.

Stability and Reactivity
Stable under recommended storage conditions. Avoid temperatures above 80°F/27°C and strong light.

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

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

Disposal Considerations
Follow local and national regulations for disposal.

Transport Information
Not regulated for transport.

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

Other Information
Revised to meet GHS SDS format requirements. For use by dental professionals only.

Catalog excerpts

PULPDENT Orthodontic Bracket Adhesive (OBA) and Ortho-Choice™ OBA Bonding Resin-1

Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: PULPDENT Orthodontic Bracket Adhesive (OBA) and Ortho-Choice™ OBA Bonding Resin 1.0 Commercial Product Name and Supplier Commercial product name / designation Ortho-Choice™ Orthodontic Bracket Adhesive (OBA) Ortho-Choice™ OBA Bonding Resin 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 Number 24 Hour Emergency: 1-800-535-5053 (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 Xi ( Irritant); 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. Precautionary Statements P261: Avoid breathing vapor.

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PULPDENT Orthodontic Bracket Adhesive (OBA) and Ortho-Choice™ OBA Bonding Resin-2

Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: PULPDENT Orthodontic Bracket Adhesive (OBA) and Ortho-Choice™ OBA Bonding Resin 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 characterization of the preparation...

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PULPDENT Orthodontic Bracket Adhesive (OBA) and Ortho-Choice™ OBA Bonding Resin-3

Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: PULPDENT Orthodontic Bracket Adhesive (OBA) and Ortho-Choice™ OBA Bonding Resin 5.3 Special exposure hazards in a fire Heat of fire may cause polymerization with rapid release of energy, especially in amounts greater than in this product. Special protective equipment for fire-fighters Self-contained breathing apparatus. Accidental Release Measures Personal precautions. Ventilate area. Wear safety glasses, gloves, and lab coat. Environmental precautions Contain uncured, spilled material. Cured/set-up material is, to...

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PULPDENT Orthodontic Bracket Adhesive (OBA) and Ortho-Choice™ OBA Bonding Resin-4

Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: PULPDENT Orthodontic Bracket Adhesive (OBA) and Ortho-Choice™ OBA Bonding Resin 9.2.5 Explosive properties Oxidizing properties Vapor pressure Specific gravity Partition coefficient Vapor density Evaporation rate Temperature > 80oF/27oC, strong visible 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 build up and release of carbon monoxide, carbon...

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PULPDENT Orthodontic Bracket Adhesive (OBA) and Ortho-Choice™ OBA Bonding Resin-5

Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: PULPDENT Orthodontic Bracket Adhesive (OBA) and Ortho-Choice™ OBA Bonding Resin 13.1 Follow all local and national government regulations in disposing material or contaminated packaging. Transport Information Regulatory Information Class IIa medical device under MDD 93/42/EEC. Class II medical device Health Canada Class II 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....

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PULPDENT Orthodontic Bracket Adhesive (OBA) and Ortho-Choice™ OBA Bonding Resin-6

Pulpdent Corporation Revision Date: June 14, 2022 Safety Data Sheet Trade Name: PULPDENT Orthodontic Bracket Adhesive (OBA) and Ortho-Choice™ OBA Bonding Resin

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