510(k) K992937 ยท DZE Implant, Endosseous, Root-Form
DENTAL IMPLANT
| Applicant | Nobel Biocare Uas, Inc., Yorba Linda CA, US |
| Decision | Substantially Equivalent, Feb 29, 2000 |
| Received | Aug 31, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992937
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2016 | Medtronic Navigation, Inc. FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes.
Product Usage:
The StealthStation System is intended as an aid for preci Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.