ProphyCare

Directa AB

Revision date : 2021-04-12

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Health risk rating 1
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

231-667-8/7681-49-4

Name of the chemical

Sodium fluoride

Concentration

<0,3

EC/CAS

223-339-8/3844-45-9

Name of the chemical

Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl-[(3-sulfophenyl)-methyl]-amino]-phenyl](2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo, inner salts, disodium salt and its ammonium and aluminium salts (17); (CI 42090)

Concentration

0.1-5

EC/CAS

217-699-5/1934-21-0

Name of the chemical

Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate and aluminium lake (17); (CI 19140)

Concentration

0,01-0,09 %

EC/CAS

240-474-8

Name of the chemical

Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate and its insoluble barium, strontium and zirconium lakes, salts and pigments

Concentration

0,01-0,09 %

General Information

Revision date

2021-04-12

Product name

ProphyCare

1.2.1 Relevant identified uses

ProphyCare PRO Paste for removal of coatings on teeth ProphyCare Paste for polishing teeth. Medical device. Directly invasive

supplier name

Directa AB

Emergency telephone

+46 (0)8- 33 12 31

Icons in SDS

M004 M009 M010 M011 M017

Company Information

company name

Directa AB

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

info@directadental.com

Section 2

SECTION 2: Hazards identification

Classification of the substance or mixture CLP The product is not classified The product is considered as a medical device and contains a substance that has an occupational exposure limit. Therefore a safety data sheet must be provided on request.

2.2 Label elements

The substance/mixture does not meet the criteria for classification and labelling.

2.3 Other hazards

PBT/vPvB: Not Classified as PBT/vPvB by current EU criteria.

2.1 Classification of the substance or mixture

CLP: The product is not classified. The product is considered as a medical device and contains a substance that has an occupational exposure limit. Therefore a safety data sheet must be provided

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