510(k) K071190 ยท EKX Handpiece, Direct Drive, Ac-Powered
ROOT ZX II
| Applicant | J. Morita USA, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Aug 17, 2007 |
| Received | Apr 30, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071190
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.