Duns Number:835556429
Device Description: 3.2mm x 16mm Tapered Internal Hex Dental Implant RBM Surface
Catalog Number
T3216RBM
Brand Name
American Dental Implant
Version/Model Number
T3216RBM
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K042462
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
0a8d9b7d-4355-46eb-8d0e-f307242e169b
Public Version Date
August 31, 2018
Public Version Number
1
DI Record Publish Date
July 31, 2018
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. | 190 |