510(k) K213947 ยท ELC Scaler, Ultrasonic
Ultrasonic Endo Activation Device (Model:Actor I pro)
| Applicant | Changzhou Bomedent Medical Technology Co.,Ltd, Changzhou, CN |
| Decision | Substantially Equivalent, Sep 8, 2022 |
| Received | Dec 17, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213947
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.