Device product
Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match the variations in mucosal thickness. The GM Exact Mini Conical abutment is provided angled. They are indicated for screw-retained multiple-unit prostheses onto implants Article Number: 115244
Z-0455-2019
Product summary
- Event
- Event 81456
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21 units
- Official record key
device-enforcement:Z-0455-2019
Official wording
Reason: Laser engraved label does not match with the item in the package
Code information: Lot Number: 800327510 UDI: (01)07899878026488(11)171110(17)221110(10)800327510
Distribution pattern: US nationwide distribution in the states of GA, TX , VA.
Derived failure modes
-
Unknown
Laser engraved label does not match with the item in the package