Duns Number:016649253
Device Description: To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic r To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Catalog Number
-
Brand Name
Abutment/Implant
Version/Model Number
3014680794
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
-
Prescription Use (Rx)
-
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
5992081d-be2a-4f94-8b07-d8d711eeb112
Public Version Date
November 26, 2020
Public Version Number
1
DI Record Publish Date
November 18, 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 | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 7 |
U | Unclassified | 2 |