510(k) K243834 ยท DZE Implant, Endosseous, Root-Form
NobelZygoma TiUltra Implant system
| Applicant | Nobel Biocare AB, Goteborg, SE |
| Decision | Substantially Equivalent, Aug 25, 2025 |
| Received | Dec 13, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243834
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.