510(k) K984104 ยท DZE Implant, Endosseous, Root-Form
ITI DENTAL IMPLANT SYSTEM
| Applicant | Straumann USA, Waltham MA, US |
| Decision | Substantially Equivalent, May 13, 1999 |
| Received | Nov 17, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984104
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2003 | Roche Diagnostics Corp. Elecsys Troponin T STAT; catalog number 2017423 Terminated |
MMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.