Protemp 4 Catalyst Paste

KCI Medical Limited

Revision date : 2025-10-22

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Health risk rating 4
Safety risk rating 1
Environmental risk rating 3

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

M004

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.

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