510(k) K093164 ยท DZE Implant, Endosseous, Root-Form
3.25 SPLINE TWIST IMPLANT, HA COATED
| Applicant | Zimmer Dental, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Dec 15, 2009 |
| Received | Oct 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093164
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2014 | Zimmer Dental Inc Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135.
Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses fo Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.