Duns Number:096010525
Device Description: Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V r Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restorations, permanent cementation of crowns and bridges, cementation of orthodontic bands, and lining of cavities. Non-Boxed
Catalog Number
51-021
Brand Name
SciPharm Glasion Glass IonomerCement
Version/Model Number
SP 51-021
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
Yes
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
K895386
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
df1fdabf-4a3d-4d99-b898-21a4d47fd210
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 03, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |