Visalys CemCore

Kettenbach GmbH & Co. KG

Revision date : 2026-03-05

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GHS07
Health risk rating 2
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

14464-46-1

Name of the chemical

Cristobalit (s. u. TRGS 906)

Concentration

30-<60%

EC/CAS

72869-86-4

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

10-<30%

EC/CAS

68909-20-6

Name of the chemical

Silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, hydrolysis products with silica

Concentration

1-<5%

Listed in

EC/CAS

94-36-0

Name of the chemical

Dibenzoyl peroxide

Concentration

0.1-<1%

EC/CAS

2440-22-4

Name of the chemical

2-(2H-benzotriazol-2-yl)-p-cresol (UV-P)

Concentration

0.1-<1%

General Information

Revision date

2026-03-05

Product name

Visalys CemCore

1.2.1 Relevant identified uses

Medical device for use in dentistry, observe instructions for use

1.2.2. Uses advised against

Observe instructions for use

Emergency telephone

49(0) 2774/705-0, +49 (0)2774/705-66

Icons in SDS

GHS07 M004 M009 M010 P002 P003

Company Information

company name

Kettenbach GmbH & Co. KG

e-mail address of the competent person responsible for the Safety Data Sheet

info@kettenbach.com

GHS Information

Signal word

Warning

Section 2

SECTION 2: Hazards identification

Classification of the chemical

Signal word

Warning

Hazard statements

May cause an allergic skin reaction Causes serious eye irritation May cause respiratory irritation

Precautionary statements

Do not breathe dust/fume/gas/mist/vapors/spray. Wear protective gloves and eye protection/face protection. If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If skin irritation or rash occurs: Get medical advice/attention. Disposal of the contents/container in accordance with local/regional/national international regulations.

2.3 Other hazards

Due to the physical form (paste), classification with H372 and H373 is not indicated. Inhalation is not possible.

2.1 Classification of the substance or mixture

29 CFR Part 1910.1200 Serious eye damage/eye irritation: Eye Irrit. 2A Respiratory or skin sensitization: Skin Sens. 1 Specific target organ toxicity single exposure: STOT SE 3 (respiratory tract irritation) *Safety Information Sheet for Medical Devices* The particulars given in the Safety Information Sheet only apply to the described product in connection with its appropriate utilization. These particulars are based on the latest state of our knowledge and information. In particular, they serve the purpose of describing our product under the aspect of hazards caused by such product and pertaining safety actions. They do not constitute any guarantee of product quality and/or quality features. The particulars given in this Safety Information Sheet are not required in accordance with FDA regulations. This product is classified as a medical device. Medical devices are exempt from the labelling provisions of GHS according to the Hazard Communication Standard (29 CFR § 1910.1200). They merely serve the purpose of providing sufficient information on the voluntary basis with a view to ensure the safe utilization of such substance/mixture/product.

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