Duns Number:316133664
Device Description: Glass ionomer luting cement, suitable for cementing crowns, bridges, inlays and onlays. Is Glass ionomer luting cement, suitable for cementing crowns, bridges, inlays and onlays. Is used in dentistry.
Catalog Number
75060
Brand Name
BISICO Glass Cem
Version/Model Number
75060
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
K011431
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
2b77dced-a3cb-43ff-bb0a-b3f59b0afbcb
Public Version Date
June 29, 2020
Public Version Number
2
DI Record Publish Date
June 10, 2020
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 | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 74 |