Duns Number:433815198
Device Description: ABUTMENT TIT. D.12 D.IMP.5.00/SW ATTACK
Catalog Number
A-CAMT-500-12-SW
Brand Name
ABUTMENT TIT. D.12
Version/Model Number
A-CAMT-500-12-SW
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
-
Product Code
NDP
Product Code Name
Accessories, Implant, Dental, Endosseous
Public Device Record Key
53bfc6d5-116e-4349-8eb7-8db27627d34a
Public Version Date
October 08, 2020
Public Version Number
1
DI Record Publish Date
September 30, 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 | 1248 |
2 | A medical device with a moderate to high risk that requires special controls. | 1062 |