Affinity Multi-Prep Extended Working Time Impression Material

SECTION 2: Hazards identification

Regulation (EC) No. 1272/2008 to specifications, the product does not have any harmful effects to our experience and the information provided to us. Requirements for storage with other products: Not required CLASSIFICATION OF THE SUBSTANCE OR MIXTURE Further information on storage conditions: None

2.2 Label elements

that have to be monitored at the workplace SECTION 13: DISPOSAL CONSIDERATION

Additional information

The lists valid during the making were used as basis Labeling according to EU guidelines: Medical devices as defined in Directive PERSONAL PROTECTIVE EQUIPMENT: PRODUCT 93/42/EEC and which are invasive or used in direct physical contact with the human General measures of protection and hygiene: Normal hygienic measures Recommendation: Small quantities can be disposed of with household

2.3 Other hazards

Eye protection: Not required UNCLEANED PACKAGING

PBT Substances

Not applicable Recommendation: Disposal must be made according to official regulations. SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES

vPvB Substances

Not applicable APPEARANCE SECTION 14: TRANSPORT INFORMATION Form: Paste Land transport ADR, RID: No subject to transport regulations

2.1 Classification of the substance or mixture

Further information on storage conditions: None Classification according to Regulation (EC) 1272/2008: Void SECTION 12: ECOLOGICAL INFORMATION Information concerning particular hazards for human and environment: SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION General information: Avoid transfer into environment The product does not have to be labeled due to the calculation procedure of the Components with limits of values to be supervised at the workplace: Classification of water endangerment: WGK 1 (German regulation) slightly “General classification guideline for preparations of the EU” in the latest valid version. The product does not contain any relevant quantities of materials with critical values hazardous for water LABEL ELEMENTS that have to be monitored at the workplace SECTION 13: DISPOSAL CONSIDERATION Labeling according to Regulation (EC) 1272/2008: Void Additional information: The lists valid during the making were used as basis. Labeling according to EU guidelines: Medical devices as defined in Directive PERSONAL PROTECTIVE EQUIPMENT: PRODUCT 93/42/EEC and which are invasive or used in direct physical contact with the human General measures of protection and hygiene: Normal hygienic measures Recommendation: Small quantities can be disposed of with household body; are exempted from the provisions of Regulation (EC) No. 1272/2008 (CLP/GHS) Respiratory protection: Not required waste. Use proper landfill disposal or incineration in accordance with local, usually if they are in the finished state and intended for the final user. Protection of hands: Not required state and federal regulations. OTHER HAZARDS Eye protection: Not required UNCLEANED PACKAGING Results of PBT and vPvB assessment PBT: Not applicable Recommendation: Disposal must be made according to official regulations. SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES vPvB: Not applicable APPEARANCE SECTION 14: TRANSPORT INFORMATION Form: Paste Land transport ADR, RID: No subject to transport regulations SECTION 3: COMPOSITION/INFORMATION OF INGREDIENTS Color: Different Maritime transport: IMDG-Code: No subject to transport regulations CHEMICAL CHARACTERIZATION Odor: Odorless Air transport ICAO-TI/IATA-DGR: No subject to transport regulations Chemical characterization: Mixture of polydimethyl polymethyl vinyl siloxane, INFORMATION ON CHANGE polydimethyl polymethyl hydrogen siloxane and silica IN THE PHYSICAL STATE VALUE UNIT METHOD SECTION 15: REGULATORY INFORMATION Hazardous components: None Melting point/melting range: n.a. °C/°F Classification according to EC-guidelines: The product is a medical Boiling point/boiling range: n.a. °C/°F device according to EC-directive 93/42 EEC. SECTION 4: FIRST-AID MEASURES Flash point: n.a. °C/°F Chemical safety assessment: A Chemical Safety Assessment has not been Autoignition temperature: n.a. First-aid measures: No special measures required carried out. Danger of explosion: none After skin contact: Wash with plenty of water and soap Density: Tray Material 1,50 (20°C/68°F) g/cm3 SECTION 16: OTHER INFORMATION After eye contact: Rinse with plenty of water and consult a doctor Wash Material 1,24 (20°C68°F) g/cm3 Changes compared with the previous version: Adaptation according to After swallowing: If symptoms persist consult a doctor Vapor pressure: n.a. mbar 1907/2006/EG, Article 31 Viscosity: paste