General Information
Revision date
2025-06-25
Product name
Omniceram Bulk Fill SDC
1.2.2. Uses advised against
This product should only be supplied or handled to dentists or dental technicians or upon their instructions
Icons in SDS
Company Information
company name
SanaPro Dental GmbH
e-mail address of the competent person responsible for the Safety Data Sheet
dentalproducts@sanapro.dental, info@omnident.de
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
Medical devices as defined in Directive 93/42/EEC on medical devices (MDD) respectively Regulation (EU) 2017/245, which are invasive or used in direct physical contact with the human body are exempt from labeling requirements of Regulation (EC) No. 1272/2008 (CLP/GHS). Although not required, classification and labeling are indicated as follows: Classification: Eye irritation, Category 2; H319 Causes serious eye irritation. Skin sensitization, Category 1; H317 May cause allergic skin reaction. Chronic aquatic toxicity, Category 3; H412 Harmful to aquatic life with long lasting effects.
Hazard pictograms
GHS07
Hazard statements
H319 Causes serious eye irritation. H317 May cause allergic skin reaction. H412 Harmful to aquatic life with long lasting effects.
Precautionary statements
P280 Wear protective gloves/protective clothing/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. P302 + P352 IF ON SKIN: Wash with plenty of soap and water. P273 Avoid release to the environment.
PBT Substances
not applicable.
vPvB Substances
not applicable.
