510(k) K213947
K213947 is an FDA 510(k) premarket notification submitted by Changzhou Bomedent Medical Technology Co.,Ltd for the device "Ultrasonic Endo Activation Device (Model:Actor I pro)". The FDA issued a decision of Substantially Equivalent on September 8, 2022. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Changzhou Bomedent Medical Technology Co.,Ltd has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 2022
- Date Received
- December 17, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scaler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 872.4850
- Review Panel
- DE
- Submission Type