510(k) K101612 ยท EKX Handpiece, Direct Drive, Ac-Powered
ZEN CORDLESS PROPHY SYSTEM
| Applicant | Discus Dental, LLC, Culver City CA, US |
| Decision | Substantially Equivalent, Jun 30, 2010 |
| Received | Jun 9, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101612
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.