510(k) K211109 ยท DZE Implant, Endosseous, Root-Form
N1 TiUltra TCC Implant System
| Applicant | Nobel Biocare Services AG, Kloten, CH |
| Decision | Substantially Equivalent, Dec 21, 2021 |
| Received | Apr 14, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211109
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2025 | Nobel Biocare . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm
. Nobel Biocare N1 TiUltra TCC RP 4.0x11mm
. Nobel Biocare N1 TiUltra TCC RP 4.0x13mm
Nobel Biocare N1 TiUltra TCC implants are intended for use as an endoss Open, Classified |
DZE | None listed |
| Aug 23, 2022 | Nobel Biocare Nobel Biocare N1 TiUltra TCC NP 3.5x13mm Open, Classified |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.