510(k) K130949 ยท DZE Implant, Endosseous, Root-Form
CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS
| Applicant | Biomet 3i, Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, Jul 30, 2013 |
| Received | Apr 5, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130949
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2015 | Biomet 3i, LLC OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm.
Dental Implants. Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.