The following data is part of a premarket notification filed by Changzhou Bomedent Medical Technology Co.,ltd with the FDA for Ultrasonic Endo Activation Device (model:actor I Pro).
| Device ID | K213947 |
| 510k Number | K213947 |
| Device Name: | Ultrasonic Endo Activation Device (Model:Actor I Pro) |
| Classification | Scaler, Ultrasonic |
| Applicant | ChangZhou BoMedent Medical Technology Co.,Ltd No.9 Changyang Road,West Taihu Science & Technology Industrial Park, Changzhou, CN 213100 |
| Contact | Yang Chunyuan |
| Correspondent | Yang Chunyuan ChangZhou BoMedent Medical Technology Co.,Ltd No.9 Changyang Road,West Taihu Science & Technology Industrial Park, Changzhou, CN 213100 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-17 |
| Decision Date | 2022-09-08 |