510(k) K111809 ยท OAT Implant, Endosseous, Orthodontic
SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS
| Applicant | Biomaterials Korea, Inc., Greenwood Village CO, US |
| Decision | Substantially Equivalent, Sep 26, 2011 |
| Received | Jun 27, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111809
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.