General Information
Revision date
2025-05-20
Product name
BIODENTINE XP (Liquid Biodentine)
1.2.1 Relevant identified uses
Medical device for dental use
1.2.2. Uses advised against
No further relevant information available
supplier name
Ivoclar Vivadent Ltd
Manufacturer Name
SEPTODONT
Icons in SDS
Company Information
company name
Ivoclar Vivadent Ltd
e-mail address of the competent person responsible for the Safety Data Sheet
SDSPacific@ivoclar.com, msds@septodont.com
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H319
Hazard statements
Code
Statements
H319
Causes serious eye irritation
Section 2
SECTION 2: Hazards identification
Classification of the substance or mixture Classification according the New Zealand’s hazard classification system GHS07 Eye irritation Category 2 H319 Causes serious eye irritation Additional information This Regulation shall not apply to substances and mixtures in the following finished forms intended for the end user medicinal products, as defined in Directive 2001/83/EC Contd. of page 1) 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;
Hazard pictograms
GHS07
Hazard statements
H319 Causes serious eye irritation.
Precautionary statements
P280 Wear eye protection / face protection. P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P337+P313 If eye irritation persists: Get medical advice/attention.
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 (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 the New Zealand’s hazard classification system GHS07 Eye irritation Category 2 H319 Causes serious eye irritation. · 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 (Contd. of page 1) (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;
