510(k) K191041 ยท OAT Implant, Endosseous, Orthodontic
Orthodontic Fixation Screw [Smart Anchor Miniscrew]
| Applicant | Gni Co., Ltd., Hwaseong, KR |
| Decision | Substantially Equivalent, Aug 28, 2020 |
| Received | Apr 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191041
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.