General Information
Version
3 (replaces version 2
Revision date
2023-09-25
Product name
BIODENTINE POWDER
1.2.1 Relevant identified uses
Medical device for dental use
1.2.2. Uses advised against
No further relevant information available
Emergency telephone
+33 (0)1 45 42 59 59, 00 353 1 8092568, 00 353 1 8379964, +32 070/245 245, 0845 4647, +41 44 251 51 51
Icons in SDS
Company Information
company name
SEPTODONT
e-mail address of the competent person responsible for the Safety Data Sheet
msds@septodont.com
GHS Information
Signal word
Not classified as hazardous
Section 2
SECTION 2: Hazards identification
Regulation (EC) No. 1272/2008 Classification of the substance or mixture
Hazard pictograms
Not classified as hazardous
Signal word
Not classified as hazardous
Hazard statements
Not classified as hazardous
2.3 Other hazards
The mixture shall not contain substances listed in accordance with Article 59(1) R.E.A.C.H as having endocrine disrupting properties, or be recognised as having endocrine disrupting properties in accordance with the criteria set out in Commission Delegated Regulation (EU) 2017/2100 or Commission Regulation (Contd. of page 1) (EU) 2018/605 in a concentration equal to or greater than 0.1%.
PBT Substances
Not applicable
vPvB Substances
Not applicable
2.1 Classification of the substance or mixture
· Classification according to Regulation (EC) No 1272/2008 : The product is not classified, according to the GB CLP regulation. · Additional information: This Regulation shall not apply to substances and mixtures in the following finished forms intended for the end user (a) medicinal products, as defined in Directive 2001/83/EC (b) medical devices, as defined in Directives 90/385/EEC and 93/42/EEC, which are invasive or used in direct physical contact with the human body, and in Directive 98/79/EC;
