General Information
Version
2.00
Revision date
2025-10-22
Product name
Protemp 4 Catalyst Paste
1.2.1 Relevant identified uses
Medical device; refer to Instructions for Use
1.2.2. Uses advised against
For use only by dental professionals
Emergency telephone
1-800-424-9300, 1-703-527-3887
Icons in SDS
Company Information
company name
KCI Medical Limited
e-mail address of the competent person responsible for the Safety Data Sheet
psops_supportteam@solventum.com
Hazard Codes
Hazard statements (CLP)
H412
Hazard statements
Code
Statements
H412
Harmful to aquatic life with long lasting effects
Section 2
SECTION 2: Hazards identification
Regulation (EC) No. 1272/2008 Classification of the substance or mixture
Hazard statements
H412 Harmful to aquatic life with long lasting effects.
Supplemental label elements
EUH208
Contains
Tert-butyl 3,5,5-trimethylperoxyhexanoate. May produce an allergic reaction.
2.3 Other hazards
For information on hazards and safe use, please consider the corresponding sections of this document. This material does not contain any substances that are assessed to be a PBT or vPvB
2.1 Classification of the substance or mixture
The retained CLP Regulation (EU) No 1272/2008 as amended for Great Britain The health and environmental classifications of this material have been derived using the calculation method, except in cases where test data are available or the physical form impacts classification. Classification(s) based on test data or physical form are noted below, if applicable. This product is a medical device as defined in Directive 93/42/EEC (MDD) respectively Regulation SI 2002 No 618, as amended (UK MDR 2002), which is invasive or used in direct physical contact with the human body, and therefore is exempt from the requirements of classification and labelling according to the retained CLP Regulation (EC) No. 1272/2008, as amended for Great Britain (Article 1, paragraph 5). Although not required, the classification and label information, as applicable, is provided below. CLASSIFICATION: Hazardous to the Aquatic Environment (Chronic), Category 3 - Aquatic Chronic 3; H412 For full text of H phrases, see Section 16.