510(k) K221847 ยท DZE Implant, Endosseous, Root-Form
Ni2 Implant System
| Applicant | Newton Implant Systems, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 11, 2024 |
| Received | Jun 24, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221847
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.