510(k) K211992 ยท OAT Implant, Endosseous, Orthodontic
Ortho MI System
| Applicant | Osteonic Co., Ltd., Guro-Gu, KR |
| Decision | Substantially Equivalent, Oct 15, 2021 |
| Received | Jun 28, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211992
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.