ALPHA-DENT® Glass Ionomer Cement - ALPHA-DENT® Glass Ionomer Cement is specially - DENTAL TECHNOLOGIES, INC.

Duns Number:148312838

Device Description: ALPHA-DENT® Glass Ionomer Cement is specially formulated for superior strength, resistance ALPHA-DENT® Glass Ionomer 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: 16.5ml Liquid

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More Product Details

Catalog Number

307.0101.001

Brand Name

ALPHA-DENT® Glass Ionomer Cement

Version/Model Number

307.0101.001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K935436

Product Code Details

Product Code

EMA

Product Code Name

Cement, Dental

Device Record Status

Public Device Record Key

3c9f0b54-e7e8-47a1-9ccd-b847492b45ac

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTAL TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 183