510(k) K050705 ยท DZE Implant, Endosseous, Root-Form
TIUNITE IMPLANTS
| Applicant | Nobel Biocare AB, Yorba Linda, CA, US |
| Decision | Substantially Equivalent, May 19, 2005 |
| Received | Mar 18, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050705
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2008 | Nobel Biocare USA LLC NobelReplace Tapered Groovy RP 4.3x10mm. These products are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to support for prosthetic devic Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.