BRASSELER Matrix1 Rapid Provisional and Lingual Matrix Material User Manual

: June 9, 2024
: BRASSELER

BRASSELER Matrix1 Rapid Provisional and Lingual Matrix Material

BRASSELER-Matrix1-Rapid-Provisional-and-Lingual-Matrix-Material-
product

Product Information

The Matrix1TM Rapid Provisional & Lingual Matrix Material is a dental product used to create temporary restorations in teeth. The product contains ingredients that have not been evaluated for their toxicity, persistence, degradability, bioaccumulation potential, and mobility in soil. The product should not be allowed to reach groundwater, watercourse, or sewage system in its undiluted form or in large quantities. The product does not contain any chemicals known to the State of California to cause cancer and birth defects or other reproductive harm.

Product Usage Instructions

Rapidly inject Matrix1 into an appropriate tray.
Insert the tray and Matrix1 intraorally.
Remove after 30 seconds.
Remove interproximal tags and load temporary C&B material.
After initial material sets, Matrix1 retains the temporary.
Finish and cement the temporary.

Note:
Before using the product, the user shall determine the suitability of the product(s) for its intended use and the user assumes all risk and liability whatsoever in connection therewith.

Matrix1™
Rapid Provisional & Lingual Matrix Material

INTENDED USE:
An impression material intended for use as a medical device for the purpose of taking initial impressions to fabricate temporary restorations.

IDENTIFICATION

IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND THE COMPANY/UNDERTAKING

PRODUCT IDENTIFIER

Trade Name: Matrix1™ Rapid Provisional & Lingual Matrix Material
Relevant Identified Uses of the Substance or Mixture and Uses
Advised Against: No further relevant information is available.
Application of the Substance/the Preparation: Impression material

DETAILS OF THE SUPPLIER OF THE SAFETY DATA SHEET Distributor:

Brasseler U.S.A. Dental, LLC
One Brasseler Blvd., Savannah, GA 31419, U.S.A.
Emergency Telephone Number: 800-841-4522
Date Of Issue: February 14, 2022

HAZARDS IDENTIFICATION

Classification of the substance or mixture

Classification according to Regulation (EC) No 1272/2008: The product is not classified according to the CLP regulation.

Label elements

Labeling according to Regulation (EC) No 1272/2008: Void
Hazard pictograms: Void
Signal word: Void
Hazard statements: Void

Other hazards
Results of PBT and vPvB assessment

PBT: Not applicable
vPvB: Not applicable

COMPOSITION/INFORMATION ON INGREDIENTS

Chemical characterization: Mixtures
Description: Addition-vulcanising 2-component silicone
Dangerous components: Void
Additional information: For the wording of the listed hazard phrases refer.

FIRST-AID MEASURES

Description of first aid measures
- General information: No special measures are required.
- After inhalation: Supply fresh air; consult a doctor in case of complaints.
- After skin contact: Generally, the product does not irritate the skin.
- After eye contact: Rinse opened eye for several minutes under running water, then consult a doctor.
- After swallowing: Do not induce vomiting. Call a doctor immediately.
Most important symptoms and effects, both acute and delayed: No further relevant information available.
Indication of any immediate medical attention and special treatment needed: No further relevant information is available.

FIREFIGHTING MEASURES

Extinguishing media
- Suitable extinguishing agents: CO2, powder, or water spray. Fight larger fires with water spray or alcohol-resistant foam.
- For safety reasons unsuitable extinguishing agents: Water with full jet.
Special hazards arising from the substance or mixture No further relevant information is available.
Advice for firefighters
- Protective equipment: No special measures are required.

ACCIDENTAL RELEASE MEASURES

Personal precautions, protective equipment, and emergency procedures Avoid contact with eyes.
Environmental precautions: Do not allow to enter sewers/surface or groundwater.
Methods and material for containment and cleaning up:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).
Reference to other sections No dangerous substances are released.
- See Section 7 for information on safe handling.
- See Section 8 for information on personal protection equipment.
- See Section 13 for disposal information.

HANDLING AND STORAGE

Precautions for safe handling: When using, do not eat, drink, or smoke.
Information about fire—and explosion protection: No special measures are required.
Conditions for safe storage, including any incompatibilities:

Storage:

Requirements to be met by storerooms and receptacles:
Protect from heat and direct sunlight. Keep the container tightly sealed.
Information about storage in one common storage facility: Not required.
Further information about storage conditions: None.
Specific end use(s) No further relevant information is available.

EXPOSURE CONTROLS/PERSONAL PROTECTION

Additional information about the design of technical facilities: No further data; see item 7.

Control parameters

Ingredients with limited values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical values that have to be monitored at the workplace.
Additional information: The lists valid during the making were used as a basis.

Exposure controls

Personal protective equipment:

General protective and hygienic measures: The usual precautionary measures are to be adhered to when handling chemicals.
Respiratory protection: Not required.
Protection of hands: Not required.
Material of gloves: Not applicable.
Penetration time of glove material: Not applicable.
Eye protection: Goggles are recommended during refilling.
Body protection: Protective work clothing.

PHYSICAL AND CHEMICAL PROPERTIES

PHYSICAL AND CHEMICAL PROPERTIES

Information on basic physical and chemical properties
General Information
Appearance:
Form:                                                    Viscous
Color:                                                   Purple
Odor                                                        Characteristic
Odor threshold:                                         Not determined.
pH-value:| Not determined.
Change in condition

Melting point/freezing point:

Initial boiling point and boiling range:

|

Undetermined.

300°C/ 572°F

Not determined. Not determined.

Other information: No further relevant information is available

STABILITY AND REACTIVITY

Reactivity: No dangerous reactions if used according to specifications.
Chemical stability: Stable if used according to specifications.
Thermal decomposition/conditions to be avoided: No decomposition if used according to specifications.
Possibility of hazardous reactions: No dangerous reactions are known.
Conditions to avoid: No further relevant information is available.
Incompatible materials: No further relevant information is available.
Hazardous decomposition products: No dangerous decomposition products are known.

TOXICOLOGICAL INFORMATION

Information on toxicological effects

Acute toxicity: Based on available data, the classification criteria are not met.

Primary irritant effect:

Skin corrosion/irritation: Based on available data, the classification criteria are not met.
Serious eye damage/irritation: Based on available data, the classification criteria are not met.
Respiratory or skin sensitization: Based on available data, the classification criteria are not met.
CMR effects (carcinogenicity, mutagenicity, and toxicity for reproduction)
Germ cell mutagenicity: Based on available data, the classification criteria are not met.
Carcinogenicity: Based on available data, the classification criteria are not met.
Reproductive toxicity: Based on available data, the classification criteria are not met.
STOT-single exposure: Based on available data, the classification criteria are not met.
STOT-repeated exposure: Based on available data, the classification criteria are not met.
Aspiration hazard: Based on available data, the classification criteria are not met.

ECOLOGICAL INFORMATION

Toxicity:

Aquatic toxicity: No further relevant information is available.
Persistence and degradability: No further relevant information is available.
Bioaccumulative potential: No further relevant information is available.
Mobility in soil: No further relevant information is available.

Additional ecological information:

General notes: Do not allow undiluted products or large quantities of them to reach groundwater, watercourse, or sewage system.
Results of PBT and vPvB assessment:
- PBT: Not applicable.
- vPvB: Not applicable.
Other adverse effects: No further relevant information is available.

DISPOSAL CONSIDERATIONS

Waste treatment methods

Recommendation: Disposal must be made according to official regulations.

Uncleaned packaging:

Recommendation: Disposal must be made according to official regulations.

TRANSPORT INFORMATION

UN-Number
ADR, ADN, IMDG, IATA| Void
---|---
UN proper shipping name
ADR, ADN, IMDG, IATA| Void
Transport hazard class(es)
ADR, ADN, IMDG, IATA Class| Void
Packing group
ADR, IMDG, IATA| Void
Environmental hazards:
Marine pollutant:| No
Special precautions for user:| Not Applicable
Transport in bulk according to Annex II of Marpol and the IBC Code: Marine pollutant:| Not Applicable No

REGULATORY INFORMATION

Safety, health and environmental regulations/legislation specific for the substance or mixture

Directive 2012/18/EU
Named dangerous substances – ANNEX I: None of the ingredients is listed.

Chemical safety assessment:
A Chemical Safety Assessment has not been carried out.

US State Regulations California Proposition 65:
This product does not contain any chemicals known to the State of California to cause cancer and birth defects or other reproductive harm.

OTHER INFORMATION
This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific product features and shall not establish a legally valid contractual relationship.

Prepared by: Peter G. Jordan

INSTRUCTIONS FOR USE

BRASSELER-Matrix1-Rapid-Provisional-and-Lingual-Matrix-Material-
fig-1

STORAGE:
Matrix1™ Rapid Provisional & Lingual Matrix Material should be stored at room temperature (64°F-82°F/18°C-28°C) and at minimum relative humidity.

Brasseler U.S.A. Dental, LLC, does not accept liability for any loss or damage, direct or consequential, arising out of the use of or the inability to use these products. Before using, the user shall determine the suitability of the product(s) for its intended use and the user assumes all risk and liability whatsoever in connection therewith.

Brasseler U.S.A. Dental, LLC
One Brasseler Blvd Savannah, GA 31419, U.S.A.
800.841.4522
BrasselerUSA.com.