510(k) K252223 ยท EKX Handpiece, Direct Drive, Ac-Powered
Alpha Endo Handpiece (Alpha Endo)
| Applicant | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD., Shenzhen, CN |
| Decision | Substantially Equivalent, Oct 16, 2025 |
| Received | Jul 16, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252223
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.