Predicta™
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Predicta™ Flow Dual Cure Bulk-fill Composite ! Safety Data Sheet according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations Date of issue: 09 November 2018 Revision date: 09 November 2018 Version: 1.0 Product form Trade name Identifiers Predicta™ Flow Dual Cure Bulk-fill Composite – Catalyst Component Predicta™ Bioactive Core Dual-Cure Core White Flowable Predicta™ Bioactive Core Dual-Cure Core Build-up Tooth Flowable Predicta™ Bioactive Core Dual-Cure Core Build-up White Stackable Predicta™ Bioactive Core Dual-Cure Core Build-up Tooth Stackable Predicta™ Bioactive Bulk Dual-Cure Restorative A1/B1 Flowable Predicta™ Bioactive Bulk Dual-Cure Restorative A2/B2 Flowable Predicta™ Bioactive Bulk Dual-Cure Restorative A1/B1 Sculptable Predicta™ Bioactive Bulk Dual-Cure Restorative A2/B2 Sculptable 5ml Dispensing Gun 17-gauge Dispensing Tips (30pcs) 19-gauge Dispensing Tips (30pcs) Dual-Cure Resin Composite Restorative Parkell Inc. 300 Executive Drive Edgewood, NY 11717 T (631) 249-1134 1.4. Emergency telephone number Emergency number SECTION 2: Hazard(s) identification 2.1. Classification of the substance or mixture GHS-US classification Skin corrosion/irritation Category 2 Causes skin irritation Serious eye damage/eye irritation Category 2A Causes serious eye irritation Skin sensitization, Category 1 May cause an allergic skin reaction Specific target organ toxicity (single exposure) Category 3 May cause respiratory irritation

Predicta™ Flow Dual Cure Bulk-fill Composite Safety Data Sheet according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations 2.2. GHS Label elements, including precautionary statements GHS-US labeling Hazard pictograms (GHS-US) Signal word (GHS-US) Hazard statements (GHS-US) Precautionary statements (GHS-US) Warning Causes skin irritation May cause an allergic skin reaction Causes serious eye irritation May cause respiratory irritation Avoid breathing mist, vapors. Wash hands thoroughly after handling. Use only outdoors or in a well-ventilated area....

Predicta™ Flow Dual Cure Bulk-fill Composite Safety Data Sheet according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations Full text of hazard classes and H-statements : see section 16 4.3. Immediate medical attention and special treatment, if necessary Treat symptomatically.

Predicta™ Flow Dual Cure Bulk-fill Composite Safety Data Sheet according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations 5.1. Suitable (and unsuitable) extinguishing media 6.4. Reference to other sections For further information refer to section 8: "Exposure controls/personal protection". For disposal of residues refer to section 13: "Disposal considerations"

Safety Data Sheet according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations 7.1. Precautions for safe handling Additional hazards when processed : Avoid creating or spreading dust. Dust may form flammable and explosive mixture with air. Precautions for safe handling : Provide good ventilation in process area to prevent formation of vapor. Avoid breathing mist, vapors,. Hygiene measures : Wash hands and other exposed areas with mild soap and water before eating, drinking or smoking and when leaving work. Contaminated work clothing should not be allowed...

Predicta™ Flow Dual Cure Bulk-fill Composite according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations Safety Data Sheet Eye protection: Chemical goggles or safety glasses Skin and body protection: Wear suitable protective clothing Respiratory protection: Wear appropriate mask. Where excessive vapor, mist, or dust may result, use approved respiratory protection equipment Other information: Do not eat, drink or smoke during use.

Predicta™ Flow Dual Cure Bulk-fill Composite Safety Data Sheet according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations 9.1. Information on basic physical and chemical properties

Predicta™ Flow Dual Cure Bulk-fill Composite Safety Data Sheet according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations The product is non-reactive under normal conditions of use, storage and transport. Stable at ambient temperature and under normal conditions of use. May polymerize on exposure to temperature rise. Additional hazards when processed. Avoid dust formation. Strong oxidizing agents. No hazardous decomposition products known at room temperature. On combustion, forms: carbon oxides (CO and CO2)

Predicta™ Flow Dual Cure Bulk-fill Composite Safety Data Sheet according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations Viscosity, kinematic Likely routes of exposure Symptoms/effects after inhalation Symptoms/effects after skin contact Symptoms/effects after eye contact Symptoms/effects after ingestion Inhalation. Ingestion. Skin and eye contact. May cause respiratory irritation. May cause an allergic skin reaction. Causes skin irritation. May cause an allergic skin reaction. Causes eye irritation. May cause gastric irritation. SECTION 12: Ecological...

Predicta™ Flow Dual Cure Bulk-fill Composite Safety Data Sheet according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations Poly(oxy-1,2-ethanediyl), .alpha.,.alpha.'-[(1-methylethylidene)di-4,1-phenylene]bis[.omega.-[(2-methyl-1-oxo-2-propenyl)oxy](41637-38-1) Listed on the United States TSCA (Toxic Substances Control Act) inventory EPA TSCA Regulatory Flag XU - XU - indicates a substance exempt from reporting under the Chemical Data Reporting Rule, (40 CFR 711). Dibenzoyl peroxide (94-36-0) Listed on the United States TSCA (Toxic Substances Control Act)...

Predicta™ Flow Dual Cure Bulk-fill Composite Safety Data Sheet according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations Listed on the AICS (Australian Inventory of Chemical Substances) Listed on IECSC (Inventory of Existing Chemical Substances Produced or Imported in China) Listed on the Japanese eNcS (Existing & New Chemical Substances) inventory Listed on the Japanese ISHL (Industrial Safety and Health Law) Listed on the Korean ECL (Existing Chemicals List) Listed on NZIoC (New Zealand Inventory of Chemicals) Listed on PICCS (Philippines Inventory...