Home GUDID D73510210020020
ALPHA II® AP
Primary DI D73510210020020
Brand ALPHA II® AP
Company DENTAL TECHNOLOGIES, INC.
Model 102.1002.002
Catalog number 102.1002.002
Device description Alpha II® AP is a radiopaque fluoride containing light-cure micro-hybrid restorative composite. The special combination of fillers form a material that is extremely durable and wear-resistant; making it ideal for Class I and II restorations yet highly polishable for use in all Class III, IV and V restorations. Alpha II® AP has optimal handling characteristics. The material can be easily manipulated without sticking to your instruments. Alpha II® contains fluorescence to provide a duplication of the natural tooth surface. Kit contains: 15 x 0.30g Composite Unit Dose (Shade C1)
Published 2016-09-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true
Product Codes# Code, Name table Code Name EBF Material, Tooth Shade, Resin
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EBF Material, Tooth Shade, Resin Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D73510210020020 Primary HIBCC 0 D73510210030000 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Dental composite resin A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be 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 15 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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