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SAFETY DATA SHEET PRIMODENT, CL2

SAFETY DATA SHEET PRIMODENT, CL2

SAFETY DATA SHEET PRIMODENT, CL2

Product catalog summary
Identification of the Substance/Preparation and Company/Undertaking
  • Product Identifier: Synthetic polymer teeth Primodent, Cross Linked 2 and Basic.
  • Recommended Use: For replacing missing teeth by making total and partial dentures.
  • Manufacturer: Polident d.o.o., Slovenia.
  • Contact: Tel: 00386 5 3304840, Email: [email protected]
Hazards Identification
  • Classification: Not applicable under Regulation 1272/2008/EC.
  • Label Elements: Not applicable.
  • Other Hazards: Avoid breathing dust generated by final working.
Composition/Information on Ingredients
  • Chemical Characterization: Mixtures based on polymethylmethacrylate, dimethacrylates, and pigments.
First Aid Measures
  • Inhalation: Move to fresh air and seek medical advice if necessary.
  • Skin Contact: Wash with water and soap; consult a physician if irritation persists.
  • Eye Contact: Rinse with water and seek medical attention if needed.
  • Ingestion: Rinse mouth and drink water; seek medical advice if necessary.
Fire-Fighting Measures
  • Extinguishing Media: Water, foam, dry powder, carbon dioxide.
  • Special Hazards: May release carbon monoxide, carbon dioxide, and organic decomposition products.
  • Advice for Firefighters: Wear self-contained breathing apparatus.
Accidental Release Measures
  • Personal Precautions: Not required.
  • Environmental Precautions: No special measures required.
  • Methods for Cleaning Up: Pick up mechanically and dispose of according to regulations.
Handling and Storage
  • Handling: Only trained personnel should handle the product; ensure good ventilation.
  • Storage: Keep in dry storage.
Exposure Controls/Personal Protection
  • General Protective Measures: Provide adequate ventilation.
  • Respiratory Protection: Use protective devices in case of dust formation.
  • Eye Protection: Wear safety goggles during mechanical processing.
Physical and Chemical Properties
  • Form: Solid
  • Color: Various colors
  • Odor: Odorless
  • Flash Point: >250ºC
  • Density: 1.17 g/cm³
  • Solubility: Insoluble in water
Stability and Reactivity
  • Chemical Stability: Stable under normal conditions.
  • Hazardous Decomposition Products: None under prescribed use; may release hazardous gases in fire.
Toxicological Information
  • Acute Oral Toxicity: Tested according to EN ISO 10993-5 (2009), met requirements.
  • Irritation and Sensitization: Tested according to EN ISO 10993-10 (2010), met requirements.
Ecological Information
  • Toxicity: No evidence of hazardous properties.
  • Persistence and Degradability: No evidence of hazardous properties.
Disposal Considerations
  • Waste Treatment: Dispose of in accordance with local, state, and national legislation.
Transport Information
  • UN Number: Not applicable.
  • Transport Hazard Class: Not dangerous according to transport regulations.
Regulatory Information
  • Classification: Class IIa medical device according to EC Directive 93/42/EEC.
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Catalog excerpts

SAFETY DATA SHEET PRIMODENT, CL2-1

SAFETY DATA SHEET according to Regulation 1907/2006/EC SYNTHETIC POLYMER TEETH PRIMODENT, CROSS LINKED 2 and BASIC IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND COMPANY/UNDERTAKING INFORMATION ON THE PRODUCT Product identifier Trade name Synthetic polymer teeth Primodent, Cross Linked 2 and Basic 1.2 Relevant identifier uses of the substance or mixture and uses advised against Recommended use Teeth are intended for replacing missing teeth by making total and partial dentures. Details of the supplier of the Safety Data Sheet Manufacturer/supplier Polident d.o.o., Dental Products Industry Volčja Draga 42, 5293 Volčja Draga, Slovenija Tel.:00386 5 3304840, Fax: 00386 5 3304870 E-mail: [email protected] Information provided by 00386 5 3304859 Emergency telephone number 00386 5 3304840 HAZARDS IDENTIFICATION Classification of the substance or mixture Classification according to Regulation 1272/2008/EC: Not applicable. Label elements Labelling according to Regulation 1272/2008/EC: Not applicable. Other hazards: Avoid breathing dust generated by final working. Results of PBT and vPvB assessment PBT: Not applicable. vPvB: Not applicable. COMPOSITION/INFORMATION ON INGREDIENTS Chemical characterization: Mixtures Description Material on the base of polymethylmethacrylate, dimethacrylates and pigments. Hazardous ingredients according to Regulation 1272/2008/EC: Not applicable FIRST AID MEASURES Description of first aid measures General information No special measures required. Inhalation Remove the casualty into fresh air. In case of complaints get medical advice. Skin contact Wash off with water and soap. Consult a physician if irritation persists. Eye contact Rinse eye with plenty of water if it is necessary seek medical attention: only mechanical effect. Ingestion Wash out mouth with water and drink water. In case of complaints get medical advice. Most important symptoms and effects, both acute and delayed

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SAFETY DATA SHEET PRIMODENT, CL2-2

SAFETY DATA SHEET according to Regulation 1907/2006/EC SYNTHETIC POLYMER TEETH PRIMODENT, CROSS LINKED 2 and BASIC None known. Indication of any immediate medical attention and special treatment needed Treat symptomatically. FIRE – FIGHTING MEASURES Extinguishing media Suitable extinguishing media Water, foam, dry powder, carbon dioxide. Unsuitable extinguishing media for safety reasons None. Special hazards arising from the substance or mixture May be released in case of fire: carbon monoxide, carbon dioxide, organic products of decomposition. Advice for firefighters Wear self-contained breathing...

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SAFETY DATA SHEET PRIMODENT, CL2-3

SAFETY DATA SHEET according to Regulation 1907/2006/EC SYNTHETIC POLYMER TEETH PRIMODENT, CROSS LINKED 2 and BASIC Hand protection Not reguired. Eye protection Wear safety goggles during mechanical processing. PHYSICAL AND CHEMICAL PROPERTIES Information on basic physical and chemical properties Appearance: Form: solid Colour: different colours Odour: odourless Changes in condition: / Melting point: Undetermined Boiling point: Undetermined Flash point: >250ºC Ignition temperature: not applicable Lower explosion limit: not determined Upper explosion limit: not determined Vapour pressure: not applicable...

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SAFETY DATA SHEET PRIMODENT, CL2-4

SAFETY DATA SHEET according to Regulation 1907/2006/EC SYNTHETIC POLYMER TEETH PRIMODENT, CROSS LINKED 2 and BASIC Hazardous to the aquatic environment: No further relevant information available, no evidence for hazardous properties Persistence and degradability: No further relevant information available, no evidence for hazardous properties Bioaccumulative potential: No further relevant information available, no evidence for hazardous properties Mobility in soil: No further relevant information available, no evidence for hazardous properties Results of PBT and vPvB assessment PBT: Not applicable....

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SAFETY DATA SHEET PRIMODENT, CL2-5

Pripravil: Janja Lipušček SAFETY DATA SHEET according to Regulation 1907/2006/EC SYNTHETIC POLYMER TEETH PRIMODENT, CROSS LINKED 2 and BASIC Pregledal: Janja Lipušček Seznanjeni: Ime in priimek Darjo Kuk Mojca Planko Datum, podpis

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.