510(k) K212785 ยท DZE Implant, Endosseous, Root-Form
Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments
| Applicant | Blue Sky Bio, LLC, Libertyville IL, US |
| Decision | Substantially Equivalent, Jun 30, 2022 |
| Received | Sep 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212785
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.