Device product
Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function
Z-0839-2015
Product summary
- Event
- Event 69835
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 units
- Official record key
device-enforcement:Z-0839-2015
Official wording
Reason: Product not approved for use in the US
Code information: Lot Number: 800115427
Distribution pattern: Nationwide Distribution including AZ, CA, NY, and MA.
Derived failure modes
-
Unknown
Product not approved for use in the US