Note: Ingredients listed on restricted chemical lists
EC/CAS
215-137-3/1305-62-0
Name of the chemical
Calcium dihydroxide
Concentration
< 3
EC/CAS
236-675-5
Name of the chemical
Titandioxid; [in Pulverform mit mindestens 1 % Partikel mit aerodynamischem Durchmesser ≤ 10 μm] (2020/217)
Concentration
<3 62-0
General Information
Version
2.00
Revision date
2025-10-21
Product name
RelyX Unicem Aplicap/Maxicap Powder
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
Solventum International Ireland Limited
e-mail address of the competent person responsible for the Safety Data Sheet
psops_supportteam@solventum.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
Regulation (EC) No. 1272/2008 Classification of the substance or mixture
Signal word
WARNING.
Hazard pictograms
GHS07 (Exclamation mark) |
Hazard statements
H319 Causes serious eye irritation.
Response
P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Supplemental label elements
EUH208
Contains
Persulfate. 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
CLP REGULATION (EC) No 1272/2008 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 (EU) 2017/745 (MDR), 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 Regulation (EC) No. 1272/2008 (CLP; Article 1, paragraph 5). Although not required, the classification and label information, as applicable, is provided below. CLASSIFICATION: Serious Eye Damage/Eye Irritation, Category 2 - Eye Irrit. 2; H319 For full text of H phrases, see Section 16.
