510(k) K163634 ยท DZE Implant, Endosseous, Root-Form
External Hex Implants
| Applicant | Southern Implants (Pty), Ltd., Guateng, ZA |
| Decision | Substantially Equivalent, Nov 6, 2017 |
| Received | Dec 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163634
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2018 | Southern Implants, (Pty.) Ltd. SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or Terminated |
NHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.