510(k) K222245 ยท OAT Implant, Endosseous, Orthodontic
ACR Screw System
| Applicant | Biomaterials Korea, Inc., Hanam-Si, KR |
| Decision | Substantially Equivalent, Aug 21, 2023 |
| Received | Jul 26, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222245
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.