510(k) K191458 ยท NHA Abutment, Implant, Dental, Endosseous
Legacy SMARTBase Abutments
| Applicant | Implant Direct Sybron Manufacturing, LLC, Thousand Oaks CA, US |
| Decision | Substantially Equivalent, Oct 10, 2019 |
| Received | May 31, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191458
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.