Note: Ingredients listed on restricted chemical lists
EC/CAS
238-455-4/14464-46-1
Name of the chemical
Cristobalit (s. u. TRGS 906)
Concentration
30-<60%
EC/CAS
276-957-5/72869-86-4
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
272-697-1/68909-20-6
Name of the chemical
Silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, hydrolysis products with silica
Concentration
1-<5%
EC/CAS
202-327-6/94-36-0
Name of the chemical
Dibenzoyl peroxide
Concentration
0.1-<1%
EC/CAS
219-470-5/2440-22-4
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
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
Hazard Codes
Hazard statements (CLP)
H317, H319, H335, H412
Hazard statements
Code
Statements
H317
May cause an allergic skin reaction
Section 2
SECTION 2: Hazards identification
1272/2008 Classification of the substance or mixture GB CLP Regulation Eye Irrit. 2; H319 Skin Sens. 1; H317 STOT SE 3; H335 Aquatic Chronic 3; H412 Full text of hazard statements: see SECTION 16 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. 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 according
2.2 Label elements
GB CLP Regulation
Hazardous Ingredients
7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate Ytterbium trifluoride dibenzoyl peroxide; benzoyl peroxide 2-(2-Hydroxy-5-methylphenyl)benzotriazole
Signal word
Warning
Hazard statements
H317 May cause an allergic skin reaction. H319 Causes serious eye irritation. H335 May cause respiratory irritation. H412 Harmful to aquatic life with long lasting effects.
Precautionary statements
P260 Do not breathe dust/fume/gas/mist/vapours/spray. P280 Wear protective gloves and eye protection/face protection. P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P333+P313 If skin irritation or rash occurs: Get medical advice/attention. P501 Dispose of 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. The fillers are not bioavailable and accordingly these substances are not considered in the
2.1 Classification of the substance or mixture
GB CLP Regulation Eye Irrit. 2; H319 Skin Sens. 1; H317 STOT SE 3; H335 Aquatic Chronic 3; H412 Full text of hazard statements: see SECTION 16. *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. 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 according to the Article 31 and Annex II of Regulation (EC) No 1907/2006 (REACH Regulation). This product is classified as a medical device. Medical devices are exempt from the labelling provisions. 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.
