510(k) K251647 ยท DZE Implant, Endosseous, Root-Form
MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System
| Applicant | Dentsply Sirona, Inc., York PA, US |
| Decision | Substantially Equivalent, Aug 21, 2025 |
| Received | May 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251647
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.