510(k) K170275 ยท EKX Handpiece, Direct Drive, Ac-Powered
Tri Auto ZX2
| Applicant | J. Morita USA, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Sep 11, 2017 |
| Received | Jan 30, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170275
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.