510(k) K964220 ยท DZE Implant, Endosseous, Root-Form
REPLACE TITANIUM IMPLANT SYSTEM
| Applicant | Steri-Oss, Inc., Yorba Linda CA, US |
| Decision | Substantially Equivalent, Mar 5, 1997 |
| Received | Oct 22, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964220
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2003 | Nobel Biocare USA Inc Nobel Biocare Replace Select Radiographic Template, part number 30159. Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.