510(k) K112730 ยท NHA Abutment, Implant, Dental, Endosseous
ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION
| Applicant | Biomet 3i, Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, Jan 13, 2012 |
| Received | Sep 20, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112730
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2016 | Biomet 3i, LLC LDA Screw SBL 3mm(D)
Item: SCRSBL1
Dental implants Terminated |
NHA | None listed |
| Aug 12, 2016 | Biomet 3i, LLC LDA Screw SBL 4mm(D)
Item: SCRSBL2
Dental implants Terminated |
NHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.