510(k) K192221 ยท DZE Implant, Endosseous, Root-Form
Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts
| Applicant | Implant Direct Sybron Manufacturing, LLC, Thousand Oaks CA, US |
| Decision | Substantially Equivalent, Jun 25, 2020 |
| Received | Aug 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192221
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2021 | Implant Direct Sybron Manufacturing LLC ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform, Open, Classified |
DZE | None listed |
| Sep 23, 2021 | Implant Direct Sybron Manufacturing LLC ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform, Open, Classified |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.