RelyX Universal Resin Cement Base Paste

Solventum International Ireland Limited

Revision date : 2025-10-20

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GHS05 GHS07
Health risk rating 4
Safety risk rating 1
Environmental risk rating 3

Note: Ingredients listed on restricted chemical lists

EC/CAS

201-297-1/80-62-6

Name of the chemical

methacrylic acid, methyl ester

Concentration

<0.5

EC/CAS

276-957-5

Name of the chemical

11,14-Dioxa-2,9-diazaheptadec-16-enoic Acid, 4,4,6,16-tetramethyl-10,15-dioxo, 2-[(2-methyl-1-oxo-2-propenyl)oxy]ethyl ester (31)

Concentration

20-

EC/CAS

212-782-2

Name of the chemical

2-Hydroxyethyl Methacrylate (30)

Concentration

<0.1 93-1 <1

EC/CAS

204-881-4

Name of the chemical

Butylated Hydroxytoluene

Concentration

< 1

General Information

Version

2.00

Revision date

2025-10-20

Product name

RelyX Universal Resin Cement Base 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 in approved indications

Emergency telephone

1-800-424-9300, 1-703-527-3887

Icons in SDS

GHS05 GHS07 M004

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

Danger

Hazard Codes

Hazard statements (CLP)

H317, H318, H412

Hazard statements

Code

Statements

H317

May cause an allergic skin reaction

Section 2

SECTION 2: Hazards identification

Regulation (EC) No. 1272/2008 Classification of the substance or mixture

Hazard pictograms

GHS05 (Corrosion) |GHS07 (Exclamation mark) | Ingredients: Ingredient CAS Nbr EC No. % by Wt Urethane dimethacrylate (UDMA) 72869-86-4 276-957-5 20 - 35 Hydroperoxide SIS 3425-61-4 222-321-7 < 2.5 Phosphorylated methacrylate 700-757-3 1 - 20 Methacrylate (HEMA) 868-77-9 212-782-2 < 0.5 Methyl methacrylate (MMA) 80-62-6 201-297-1 < 0.5

Hazard statements

H318 Causes serious eye damage. H317 May cause an allergic skin reaction. H412 Harmful to aquatic life with long lasting effects.

Response

P333 + P313 If skin irritation or rash occurs: Get medical advice/attention. 9% of the mixture consists of components of unknown acute oral toxicity. 9% of the mixture consists of components of unknown acute dermal toxicity.

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 material has been tested for eye damage/irritation and the test results are reflected in the assigned classification. 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 1 - Eye Dam. 1; H318 Skin Sensitization, Category 1 - Skin Sens. 1; H317 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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