510(k) K220978 ยท DZE Implant, Endosseous, Root-Form
TSX Implants
| Applicant | Biomet 3i, LLC, Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, Sep 14, 2022 |
| Received | Apr 4, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220978
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.