510(k) K213677 ยท DZE Implant, Endosseous, Root-Form
Bonafix 2 Plus
| Applicant | Zentek Medical, LLC, Manalapan NJ, US |
| Decision | Substantially Equivalent, Dec 20, 2022 |
| Received | Nov 22, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213677
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.