510(k) K231087 ยท DZI Drill, Bone, Powered
Guided Surgery Kit
| Applicant | Implant Direct Sybron Manufacturing, LLC, Thousand Oaks CA, US |
| Decision | Substantially Equivalent, Aug 16, 2023 |
| Received | Apr 17, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231087
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.