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
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
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
EMA
Product Code Name
Cement, Dental
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 183 |