510(k) K223535 ยท NHA Abutment, Implant, Dental, Endosseous
SMARTbase Abutment System
| Applicant | Implant Direct Sybron Manufacturing, LLC, Thousand Oaks CA, US |
| Decision | Substantially Equivalent, Jun 20, 2023 |
| Received | Nov 23, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223535
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2023 | Implant Direct Sybron Manufacturing LLC LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE;
LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE;
LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE;
LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE
LEGACY S Open, Classified |
NHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.