BracePaste Fluoride Sealant

American Orthodontics

Revision date : 2024-10-15

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GHS07 GHS08
Health risk rating 4
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

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

50%

EC/CAS

218-218-1/2082-81-7

Name of the chemical

methacrylic acid, diester with 1,4-butanediol

Concentration

25%

EC/CAS

278-355-8/75980-60-8

Name of the chemical

Diphenyl(2,4,6-trimethylbenzoyl)phosphinoxid

Concentration

<2.5%

General Information

Revision date

2024-10-15

Product name

BracePaste Fluoride Sealant

Product Synonyms

Bonding Agents

1.2.1 Relevant identified uses

Dental/Orthodontic use only

Icons in SDS

GHS07 GHS08

Company Information

company name

American Orthodontics

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

info@americanortho.com

GHS Information

Signal word

Warning

Hazard Codes

Hazard statements (CLP)

H317, H361

Hazard statements

Code

Statements

H317

May cause an allergic skin reaction

Section 2

SECTION 2: Hazards identification

2.1.1 Classification according to Regulation (EC) No 1272/2008 (CLP/GHS) Classification of the substance or mixture

2.2 Label elements

The product is classified and labeled according to the Globally Harmonized System (GHS).

Signal word

Warning

Hazardous Ingredients

Diurethane dimethacrylate Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide Tetramethylene dimethacrylate

Hazard statements

H317 May cause an allergic skin reaction. [Pertains to the following ingredients / component parts: Diurethane dimethacrylate, Diphenyl(2,4,6- trimethylbenzoyl)phosphine oxide, Tetramethylene dimethacrylate] H361 Suspected of damaging fertility of the unborn child. [Pertains to the following ingredients / component parts: Tetramethylene dimethacrylate]

Precautionary statements

P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P261 Avoid breathing dust/fume/gas/mist/vapors/spray. P272 Contaminated work clothing must not be allowed out of the workplace. P280 Wear protective gloves/protective clothing/eye protection/face protection. P302 + P352 IF ON SKIN: Wash with plenty of soap and water. P308 + P313 IF exposed or concerned: Get medical advice/attention. P321 Specific treatment (see on this label). P333 + P313 If skin irritation or rash occurs: Get medical advice/attention. P363 Wash contaminated clothing before reuse. P405 Store locked up. P501 Dispose of contents/container in accordance with local/regional/national/international regulations.

PBT Substances

Not Applicable

vPvB Substances

Not Applicable

2.1 Classification of the substance or mixture

2.1.1 Classification according to Regulation (EC) No. 1272/2008 [CLP] Skin Sens 1. H317 May cause an allergic skin reaction [Pertains to the following ingredients / component parts: Diurethane dimethacrylate, Diphenyl(2,4,6- trimethylbenzoyl)phosphine oxide, Tetramethylene dimethacrylate] Repr. 2 H361 Suspected of damaging fertility or the unborn child. [Pertains to the following ingredients / component parts: Tetramethylene dimethacrylate] 2.1.2 Reference to Other Sections: See Section 7 for information on Safe Handling. See Section 8 for information on Personal Protective Equipment. See Section 13 for Disposal Information. * NOTE: The above information pertains only to the ingredients or raw materials used to make this product. Biocompatibility testing was performed on the finished product (BracePaste Fluoride Sealant); BracePaste Fluoride Sealant is biocompatible per ISO 7405, ISO 10993-1.

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