Device product
Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Z-0019-2020
Product summary
- Event
- Event 83198
- Status
- Terminated
- Classification
- Class II
- Quantity
- 167 units
- Official record key
device-enforcement:Z-0019-2020
Official wording
Reason: Surface micro/nano topography on some of the implants contained within this lot may not be consistently present over the entire surface of the implant.
Code information: Lot Number: W0-008254 UDI: 729010869611020-70024P
Distribution pattern: AL AZ CA CO FL GA MA MD MO MT NJ NM NY OH SC VA
Derived failure modes
-
Unknown
Surface micro/nano topography on some of the implants contained within this lot may not be consistently present over the entire surface of the implant.