510(k) K242514 ยท EKX Handpiece, Direct Drive, Ac-Powered
Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)
| Applicant | Shenzhen Rogin Medical Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Apr 24, 2025 |
| Received | Aug 23, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242514
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.