Home GUDID D73530500020010 ALPHA-DENT® Zinc Phosphate Cement
Primary DI D73530500020010
Brand ALPHA-DENT® Zinc Phosphate Cement
Company DENTAL TECHNOLOGIES, INC.
Model 305.0002.001
Catalog number 305.0002.001
Device description ALPHA-DENT® Zinc Phosphate Cement is specially formulated for superior strength, resistance to dissolution, and oral retention. They are impervious to oral fluids, and thus permanent under oral conditions. The material is recommended for cementing crowns, inlays, orthodontic bands, temporary fillings, fixed bridges, or as a base under any filling material. Kit Contains: 32g Powder (White), 16.5ml Liquid, Measuring Scoop
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 EMA Cement, Dental
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EMA Cement, Dental Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D73530500020010 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Zinc phosphate dental cement A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an oxide powder [the principal constituent of which is zinc oxide (ZnO)] and an aqueous solution of phosphoric acid. It typically includes some additional fillers/components. 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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