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

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...

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,...

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,...

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...

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