510(k) K243078 ยท DZE Implant, Endosseous, Root-Form
HexaPLUS S OneDrill Implant System
| Applicant | Osseofuse International, Inc., Las Vegas NV, US |
| Decision | Substantially Equivalent, Oct 10, 2025 |
| Received | Sep 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243078
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.