510(k) K192649 ยท EKX Handpiece, Direct Drive, Ac-Powered
Endo Motor
| Applicant | Foshan Cicada Dental Instrument Co, Ltd., Nanhai District, Foshan, CN |
| Decision | Substantially Equivalent, Mar 12, 2021 |
| Received | Sep 24, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192649
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.