K213677 is an FDA 510(k) clearance for the Bonafix 2 Plus. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Zentek Medical, LLC (Manalapan, US). The FDA issued a Cleared decision on December 20, 2022, 393 days after receiving the submission on November 22, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K213677 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 2021 |
| Decision Date | December 20, 2022 |
| Days to Decision | 393 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZE - Implant, Endosseous, Root-form |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3640 |