510(k) K891613 ยท DZE Implant, Endosseous, Root-Form
OVERDENTURE ATTACHMENT
| Applicant | Implant Innovations International, Inc., West Palm Beach FL, US |
| Decision | Substantially Equivalent, Oct 10, 1989 |
| Received | Mar 20, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891613
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2016 | Biomet 3i, LLC O-Ring Abutment 4.1mm(D) x 2mm(H)
Item: OSO20
Dental implants Terminated |
DZE | None listed |
| Aug 12, 2016 | Biomet 3i, LLC O-Ring Abutment 4.1mm(D) x 4mm(H)
Item: OSO40
Dental implants Terminated |
DZE | None listed |
| Aug 12, 2016 | Biomet 3i, LLC O-Ring Abutment 4.1mm(D) x 6mm(H)
Item: OSO60
Dental implants Terminated |
DZE | None listed |
| Aug 12, 2016 | Biomet 3i, LLC DAL-RO Housing, Female Assembly
Dental implants Terminated |
DZE | None listed |
| Aug 12, 2016 | Biomet 3i, LLC DAL-RO Abutment
Dental implants Terminated |
DZE | None listed |
| Aug 12, 2016 | Biomet 3i, LLC DAL-RO Threaded Female
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.