510(k) K950204 ยท DZE Implant, Endosseous, Root-Form
3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS, MINIPLANTS (TM)
| Applicant | Implant Innovations, Inc., West Palm Baeach FL, US |
| Decision | Substantially Equivalent, Sep 27, 1995 |
| Received | Jan 18, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950204
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2007 | Biomet 3i Product is labeled as LTX XP Miniplant, Dental Implant, Sterile. Terminated |
DZE | None listed |
| Mar 20, 2003 | Implant Innovations, Inc. LTX Endosseous Implant 6.0 mm X 11.5 mm and also LTX Endosseous Implant 5.0 mm X 15 mm, Sterile, Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.