K213947 is an FDA 510(k) clearance for the Ultrasonic Endo Activation Device (Model:Actor I pro). This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by Changzhou Bomedent Medical Technology Co.,Ltd (Changzhou, CN). The FDA issued a Cleared decision on September 8, 2022, 265 days after receiving the submission on December 17, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K213947 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2021 |
| Decision Date | September 08, 2022 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELC — Scaler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4850 |