510(k) K972444 ยท DZE Implant, Endosseous, Root-Form
3I INNOVATIVE IMPLANTS AND COVER SCREWS
| Applicant | Implant Innovations, Inc., Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, Aug 26, 1997 |
| Received | Jun 30, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972444
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2016 | Biomet 3i, LLC Certain Titanium Large Hexed Screw
Dental implants Terminated |
DZE | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Gingihue TM 15 degree Angled Post
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.