510(k) K191276 ยท EKX Handpiece, Direct Drive, Ac-Powered
Dental Electrical Motor iRoot Pro
| Applicant | Changzhou Bomedent Medical Technology Co.,Ltd, Changzhou, CN |
| Decision | Substantially Equivalent, Jun 30, 2020 |
| Received | May 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191276
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.