Home GUDID D73540101030020 Alpha-Seal®
Primary DI D73540101030020
Brand Alpha-Seal®
Company DENTAL TECHNOLOGIES, INC.
Model 401.0103.002
Catalog number 401.0103.002
Device description "Alpha-Seal® is a light cure resin-based Pit & Fissure Sealant with fluoride. This sealant contains 50% radiopaque nano-sized fillers. The hard setting, wear resistant material has an ideal flowable viscosity for maximum coverage and protection to seal the pits and fissures of teeth suseptible to caries. The syringe needle tips allow for quick and accurate placement of the material. Alpha-Seal® is available in Opaque shade to allow for easy identification during patient examinations and in a Clear shade for patients who wish to have an ""invisible"" sealant. Kit Contains: 1 x 1.5g Sealant Syringe (Opaque White), 3 Dispensing Tips"
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 D73540101030020 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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