510(k) K073142 ยท DZE Implant, Endosseous, Root-Form
NOBELREPLACE HEXAGONAL IMPLANT
| Applicant | Nobel Biocare USA, LLC, Yorba Linda, CA, US |
| Decision | Substantially Equivalent, Jan 11, 2008 |
| Received | Nov 7, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K073142
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2021 | Nobel Biocare Usa Llc NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R Terminated |
DZE | None listed |
| Jul 20, 2020 | NOBEL BIOCARE SERVICES AG NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supportin Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.