510(k) K081653 ยท DZE Implant, Endosseous, Root-Form
MDI MII ONE-PIECE IMPLANT, 2.9MM
| Applicant | Imtec Corp., Ardmore OK, US |
| Decision | Substantially Equivalent, Sep 19, 2008 |
| Received | Jun 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081653
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2009 | IMTEC Corporation MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm, endosseous dental implant.
The product is used as a endosseous dental implant. Terminated |
KKO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.