510(k) K032263 ยท DZE Implant, Endosseous, Root-Form
3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR
| Applicant | Implant Innovations, Inc., Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, Jan 28, 2004 |
| Received | Jul 23, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032263
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2014 | Biomet 3i, LLC Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Ab Terminated |
NHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.