510(k) K243692 ยท EKX Handpiece, Direct Drive, Ac-Powered
EnDrive (EnDriveUS)
| Applicant | Advanced Technology Research (A.T.R.) S.R.L., Pistoia, IT |
| Decision | Substantially Equivalent, Aug 22, 2025 |
| Received | Nov 29, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243692
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.