General Information
Revision date
2023-06-06
Product name
BIODENTINE XP POWDER
1.2.1 Relevant identified uses
Medical device for dental use
Emergency telephone
1-800-424-9300, +1 703-527-3887
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
Void
Section 2
SECTION 2: Hazards identification
2.1 Classification of the substance or mixture
The product is not classified, according to the Globally Harmonized System (GHS).
Additional information
This Regulation shall not apply to substances and mixtures in the following forms, in their finished state, 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;
2.2 Label elements
Void
Hazard pictograms
Void
Signal word
Void
Hazard statements
Void
Classification system
NFPA ratings (scale 0 - 4) Health = 0 0 Fire = 0 0 Reactivity = 0 (Contd. of page 1) · HMIS-ratings (scale 0 - 4) HEALTH 0 Health = 0 FIRE 0 Fire = 0 REACTIVITY 0 Reactivity = 0
2.3 Other hazards
The mixture does not contain substances listed in accordance with Article 59(1) of REACH as having endocrine disrupting properties, or is not known to have endocrine disrupting properties in accordance with the criteria set out in Commission Delegated Regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at a concentration equal to or greater than 0.1% .
PBT Substances
Not applicable
vPvB Substances
Not applicable
