Duns Number:344038836
Device Description: CERCON® Abutment dentin, angled D3.8/GH2/A15
Catalog Number
47-2242
Brand Name
FRIADENT®
Version/Model Number
32472242
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 06, 2020
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
-
Product Code
NHA
Product Code Name
ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
Public Device Record Key
03fcea03-520e-40b8-a8cd-704e0e3764a4
Public Version Date
December 07, 2020
Public Version Number
5
DI Record Publish Date
October 24, 2015
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 | 1379 |
2 | A medical device with a moderate to high risk that requires special controls. | 2266 |