510(k) K160825 ยท EKX Handpiece, Direct Drive, Ac-Powered
MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology
| Applicant | Dentsply Sirona, York PA, US |
| Decision | Substantially Equivalent, Sep 27, 2016 |
| Received | Mar 25, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160825
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.