510(k) K190491 ยท NHA Abutment, Implant, Dental, Endosseous
Blue Sky Bio Zygomatic Implant System
| Applicant | Blue Sky Bio, LLC, Libertyville IL, US |
| Decision | Substantially Equivalent, Aug 12, 2019 |
| Received | Feb 28, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190491
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.