Duns Number:484609081
Device Description: Ti Hybrid part with Screw compatible to Biodenta Bone Level B0 GH0.75
Catalog Number
CAD-THABBLB0S
Brand Name
Biodenta
Version/Model Number
CAD-THABBLB0S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
abed5832-8ea1-488b-bb77-4dadde511734
Public Version Date
June 29, 2020
Public Version Number
1
DI Record Publish Date
June 20, 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 | 43 |
2 | A medical device with a moderate to high risk that requires special controls. | 193 |