Home GUDID D73520901010010 ALPHA-DENT® One Step Primer
Primary DI D73520901010010
Brand ALPHA-DENT® One Step Primer
Company DENTAL TECHNOLOGIES, INC.
Model 209.0101.001
Catalog number 209.0101.001
Device description ALPHA-DENT® One Step Primer is part of the Paste-Primer system formulated to bond to metal, ceramic and plastic brackets. Kit Contains: 1 x 12ml Primer
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 DYH Adhesive, Bracket And Tooth Conditioner, Resin
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D73520901010010 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Dentine bonding agent/set A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. 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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