General Information
Revision date
2024-09-16
Product name
Omnicem SE base
Chemical name
This product is a medical device in accordance with Directive 93/42/EEC on medical devices or Regulation(EU) 2017/7435 (MDR), which is used invasively or in contact with the body. It is therefore exempt from theclassification and labelling requirements of Regulations (EC) 1907/2006 (REACH, Art. 2 (6) c)) and (EC)1272/2008 ((UK) CLP, Article I (5) a). A safety data sheet is not required by law for this product. This information is provided on a voluntary basisin the form of this Medical Devices Data Sheet. - Product category Dental medical device : Article category The information relevant for the application and for the safety of users and patients is defined in the product-specific directions for use.The instructions for use must be observed. The product should only be applied by a professionally trained dental practitioner
1.2.1 Relevant identified uses
Dental luting cement
supplier name
OMNIDENT Dental-Handelsgesellschaft mbH
Manufacturer Name
MP Medical Product GmbH
Icons in SDS
Company Information
company name
MP Medical Product GmbH
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H317, H319, H412
Hazard statements
Code
Statements
H317
May cause an allergic skin reaction
Section 2
SECTION 2: Hazards identification
2.1 Classification of the substance or mixture
- Classification
PBT Substances
Not applicable - vPyB: Not applicable.
