Duns Number:081290972
Device Description: T-Base Abutment for Transepithelial Connector Non Engaging D.3.4 mm.
Catalog Number
-
Brand Name
AoN Implants
Version/Model Number
ALS34000TERO0
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
e70ac44e-6706-4160-9c7d-20c0c7b9df11
Public Version Date
December 23, 2021
Public Version Number
1
DI Record Publish Date
December 15, 2021
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 | 425 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1392 |