Duns Number:689514395
Device Description: Endosseous Dental Implant Abutment
Catalog Number
DAB6515N
Brand Name
Implantium, Superline
Version/Model Number
DAB6515N
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K172640
Product Code
NHA
Product Code Name
ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
Public Device Record Key
7270581d-76b6-4f06-a3b8-7ad8f00e7394
Public Version Date
November 30, 2020
Public Version Number
1
DI Record Publish Date
November 21, 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 | 835 |
2 | A medical device with a moderate to high risk that requires special controls. | 1469 |