BRASSELER USA Accur8 Hydroactive Impression Material Instruction Manual

BRASSELER USA Accur8 Hydroactive Impression Material

MATERIAL IDENTIFICATION & INFORMATION

• MATERIAL NAME : Accur8™ V.P.S.
• USE OR PREPARATION : Impression Material
• DISTRIBUTOR : Brasseler U.S.A. Dental, LLC One Brasseler Blvd. Savannah, GA 31419, U.S.A.
• TELEPHONE : 800-841-4522
• DATE OF ISSUE : March 2015
• DATE OF REVISION : June 1, 2022

HAZARDS IDENTIFICATION

CLASSIFICATION OF THE SUBSTANCE OR MIXTURE
Classification according to Regulation (EC) 1272/2008: Void Information concerning particular hazards for human and environment: The product does not have to be labeled due to the calculation procedure of the “General classification guideline for preparations of the EU” in the latest valid version.

LABEL ELEMENTS:
Labeling according to Regulation (EC) 1272/2008: Void Labeling according to EU guidelines: Medical devices as defined in Directive 93/42/EEC and which are invasive or used in direct physical contact with the human body; are exempted from the provisions of Regulation (EC) No. 1272/2008 (CLP/GHS) usually if they are in the finished state and intended for the final user.

OTHER HAZARDS

• PBT : Not applicable
• PvB : Not applicable

COMPOSITION/INFORMATION OF INGREDIENTS
CHEMICAL CHARACTERIZATION

• Description : Mixture of polydimethyl polymethyl vinyl siloxane, polydimethyl polymethyl hydrogen siloxane and silica
• Hazardous components : None

FIRST AID MEASURES

• General information : No special measures required
• After skin contact : Wash with plenty of water and soap
• After eye contact : Rinse with plenty of water and consult a doctor
• After swallowing : If symptoms persist consult a doctor

FIRE FIGHTING MEASURES

• Extinguishing media : CO2, water
• Protective equipment : No special measures required

ACCIDENTAL RELEASE MEASURES

• Personal precautions : Not required
• Environmental precautions: No special measures required
• Methods for cleaning up : Pick up mechanically
• Additional information : None

HANDLING AND STORAGE

HANDLING:

• Information for safe handling: For dental use only. No special measures required.
• Recommendation for fire and explosion protection : No special measures required

STORAGE:

• Requirements at storerooms and containers: No special measures required
• Requirements for storage with other products : Not required
• Further information on storage conditions : None

EXPOSURE CONTROLS/PERSONAL PROTECTION

Components with limits of values to be supervised 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 basis.

PERSONAL PROTECTIVE EQUIPMENT

• General measures of protection and hygiene : Normal hygienic measures
• Respiratory protection : Not required
• Protection of hands : Not required
• Eye protection : Not required

PHYSICAL AND CHEMICAL PROPERTIES

APPEARANCE:

• Form : Paste
• Color : Different
• Odor : Odorless

INFORMATION ON CHANGE IN THE PHYSICAL STATE Value Unit Method

• Melting point/melting range : n.a. °C
• Boiling point/boiling range : n.a. °C
• Flash point : n.a. °C
• Autoignition temperature: n.a.
• Danger of explosion : none
• Density:
  • Heavy Body RS/FS 1,46 (20°C) g/cm3
  • Rigid Tray RS/FS 1,49 (20°C) g/cm3
  • Light Body HF RS/FS 1,24 (20°C) g/cm3
  • Bite Registration 1,52 (20°C) g/cm3
• Vapor pressure : n.a. mbar
• Viscosity : paste
• pH : neutral
• Solubility in/miscibility with : Partially soluble in toluene, petrol ether
• Water : insoluble
• Content of solvents : none
• Organic solvents : —–
• Water : —–
• Content of solids : n.a.

STABILITY AND REACTIVITY
Conditions to avoid: No decomposition if used according to specification Hazardous decomposition products: None under normal conditions of storage and use

TOXICOLOGICAL INFORMATION

ACUTE TOXICITY

PRIMARY IRRITATION:

• Skin: No irritating effect
• Eye : No irritating effect
• Additional toxicological information : When used and handled according to specifications, the product does not have any harmful effects to our experience and the information provided to us.

ECOLOGICAL INFORMATION
General information Avoid transfer into environment Classification of water endangerment: WGK 1 (German regulation) slightly hazardous for water

DISPOSAL CONSIDERATIONS

PRODUCT:
Recommendation: Small quantities can be disposed of with household waste. Use proper landfill disposal or incineration in accordance with local, state and federal regulations.

UNCLEANED PACKAGING:
Recommendation: Disposal must be made according to official regulations

TRANSPORT INFORMATION

• Land transport ADR, RID: Not subject to transport regulations
• Maritime transport : IMDG-Code: Not subject to transport regulations
• Air transport ICAO-TI/IATA-DGR : Not subject to transport regulations

REGULATORY INFORMATION

• Classification according to EC-guidelines : The product is a medical device according to EC-directive 93/42 EEC.
• 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
Changes compared with the previous version: Adaptation according to 1907/2006/EG, Article 31 Prepared by: Peter G. Jordan The above information is based on our present day knowledge and relatessolely to the safety requirements of the product. The data do not signify any warranty with regards to products properties. However users of the product should satisfy themselves that the information given is sufficient and correct for their specific circumstances of use. N/D: NOT DETERMINED N/A: NOT APPLICABLE

INTENDED USE

A vinyl poly siloxane material to be used as a medical device for the purposes of creating, via impression, a reproduction of tooth andgum structure. Accur8™ VPS Impression Material from Brasseler U.S.A. Dental, LLC, is the first 3rd generation vinyl poly siloxane impression material. Accur8’s advanced 3rd generation chemistry provides true hydroactive properties, higher tear strength and dimensional stability. In addition, each viscosity is matched to all others resulting in a superior impression, regardless of the technique utilized. Accur8 also exhibits the most efficient working and set timesto minimize chair time and the potential for inaccuracies. Accur8’s dispensing is even advanced in that Accur8 flows more easily through a conventional mixing tip as compared to previous generation impression materials, regardless of the viscosity. 3rd generation Accur8 will consistently provide you with the most efficient and accurate impression.

INSTRUCTIONS FOR AUTO-MIX CARTRIDGES

1. Insert the flange at the rear of the cartridge into the space provided at the front of the impression gun – depress the gun lever to lock the cartridge in place.
2. Twist off and dispose of the cartridge shipping cap.
3. Attach a mixing tip and twist 1/4 turn to lock it into position; the mixing is done automatically inside the mixing tip.
4. Before filling the tray, it is recommended to discard the initially mixed (peasized) amount of the material. Check to ensure both base and catalyst are expressing freely.
5. Gently squeeze the impression gun handle to mix and dispense the impression material. Release handle to stop the flow.
6. Leave the used auto-mix tip on the cartridge as a self sealer after each use. For subsequent dispensing remove and discard the sealer tip. Proceed with steps 3 through 6.

MIXING/SETTING TIMES

AVAILABLE MINIMUM INTRAORAL MAXIMUM TOTAL CURE TIME ACCUR8 VPS IMPESSION MATERIAL COLOR WORKING TIME SET TIME FROM START OF MIX

• LIGHT BODY REGULAR SET LIGHT GREEN 2:00 min 3:30 min 5:30 min. Meets the requirements of ISO 4823 (type 3)
• LIGHT BODY FAST SET LIGHT PURPLE 1:00 min 1:45 min 2:45 min. Meets the requirements of ISO 4823 (type 3)
• HEAVY BODY REGULAR SET DARK TEAL 2:00 min 3:30 min 5:30 min. Meets the requirements of ISO 4823 (type 2)
• HEAVY BODY FAST SET DARK BLUE 1:00 min 1:45 min 2:45 min. Meets the requirements of ISO 4823 (type 2)
• RIGID TRAY REGULAR SET PURPLE 2:00 min 3:30 min 5:30 min. Meets the requirements of ISO 4823 (type 1)
• RIGID TRAY FAST SET TEAL 1:00 min 1:45 min 2:45 min. Meets the requirements of ISO 4823 (type 1)
• BITE REGISTRATION YELLOW 0:30 min 0:45 min 1:15 min.

ACCUR8 REGULAR SET MATERIALS HAVE A FASTER TOTAL CURE TIME COMPARED TO PREVIOUS GENERATION FAST SET MATERIALS. ACCUR8 FAST SET MATERIALS ARE RECOMMENDED FOR SINGLE PREPARATIONS ONLY.

VINYL POLY SILOXANE IMPRESSION MATERIAL CONSIDERATIONS

1. Allow impression material to reach room temperature prior to use.
2. Handling retraction cord with latex gloves may subsequently prevent the setting of the impression material if direct contact occurs.
3. Prior to taking impression, use pre-impression cleansing gel to decontaminate the preparation site.

PLEASE NOTE

• Sulpha-based drugs may inhibit the set time of VPS material.
• For model fabrication, Accur8 is ideally poured two hours after the impression has been taken. However, Accur8 can be poured sooner if the impression is placed in hot water for ten minutes to allow for degassing to occur.

STORAGE
Vinyl Poly Siloxane impression material should be stored at room temperature (65°-75°F/18°-24°C) and at minimum relative humidity. Ensure adequate ventilation of the premises where this product is handled and stored.

WARRANTY

Brasseler U.S.A. Dental, LLC, will replace any Accur8 VPS Impression Material, free of charge, if proven to be defective, and when stored according to the manufacturer’s specifications. Brasseler U.S.A. Dental, LLC, does not acceptliability 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

References

• Brasseler USA | By Your Side

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