Home GUDID D73540100000010 ALPHA-DENT® Light Cure Pit & Fissure Sealant
Primary DI D73540100000010
Brand ALPHA-DENT® Light Cure Pit & Fissure Sealant
Company DENTAL TECHNOLOGIES, INC.
Model 401.0000.001
Catalog number 401.0000.001
Device description ALPHA-DENT® Light Cure Pit & Fissure Sealant is a hard-setting, wear resistent, un-filled resin based material that has ideal flowable viscosity for maximum coverage and protection to seal pits and fissures of teeth susceptible to caries. Kit Contains: 2 x 3ml Sealant (Opaque White), 7ml Etch Liquid, Dispensing Pad
Published 2016-09-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name EBC Sealant, Pit And Fissure, And Conditioner
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EBC Sealant, Pit And Fissure, And Conditioner Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D73540100000010 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Dental pit/fissure sealant A resin-based dental material suitable for sealing pits and fissures on teeth. It may be chemically cured or external energy cured. After application, this device cannot be reused.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 27 Degrees Celsius
Regulatory Flags# DUNS number 148312838 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D73550100050020 Alpha-Etch® 37 501.0005.002 501.0005.002 2016-09-23 D73550100060020 Alpha-Etch® 37 501.0006.002 501.0006.002 2016-09-23 D73550101030020 Alpha-Etch® 37 501.0103.002 501.0103.002 2016-09-23 D73550101050020 Alpha-Etch® 37 501.0105.002 501.0105.002 2016-09-23 D73550102030020 Alpha-Etch® 37 501.0203.002 501.0203.002 2016-09-23 D73550102050020 Alpha-Etch® 37 501.0205.002 501.0205.002 2016-09-23 D73550112040020 Alpha-Etch® 37 501.1204.002 501.1204.002 2016-09-23 D73550112110020 Alpha-Etch® 37 501.1211.002 501.1211.002 2016-09-23 D73550112130020 Alpha-Etch® 37 501.1213.002 501.1213.002 2016-09-23 D73550301020010 ALPHA-DENT® Etchant Liquid 503.0102.001 503.0102.001 2016-09-23 D73550301030010 ALPHA-DENT® Etchant Liquid 503.0103.001 503.0103.001 2016-09-23 D73550302030010 ALPHA-DENT® Etchant Liquid 503.0203.001 503.0203.001 2016-09-23 D73550302050010 ALPHA-DENT® Etchant Liquid 503.0205.001 503.0205.001 2016-09-23 D73520000000010 ALPHA-DENT® Self Cure Bonding Adhesive 200.0000.001 200.0000.001 2016-09-23 D73520000010010 ALPHA-DENT® Self Cure Bonding Adhesive 200.0001.001 200.0001.001 2016-09-23 D73520001020010 ALPHA-DENT® Self Cure Bonding Adhesive 200.0102.001 200.0102.001 2016-09-23 D73520002020010 ALPHA-DENT® Self Cure Bonding Adhesive 200.0202.001 200.0202.001 2016-09-23 D73520600000010 ALPHA-DENT® Light Cure Bonding Adhesive 206.0000.001 206.0000.001 2016-09-23 D73520600010010 ALPHA-DENT® Light Cure Bonding Adhesive 206.0001.001 206.0001.001 2016-09-23 D73520601010010 ALPHA-DENT® Light Cure Bonding Adhesive 206.0101.001 206.0101.001 2016-09-23
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