510(k) K161335 ยท OAT Implant, Endosseous, Orthodontic
Dual Top Screw System
| Applicant | Jeil Medical Corporation, Seoul, KR |
| Decision | Substantially Equivalent, Feb 23, 2017 |
| Received | May 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161335
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.