510(k) K211531 ยท EKX Handpiece, Direct Drive, Ac-Powered
Cordless Prophy System, Model: i-Polish
| Applicant | Guilin Woodpecker Medical Instrument Co., Ltd., Guilin, CN |
| Decision | Substantially Equivalent, Dec 17, 2021 |
| Received | May 17, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211531
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.