510(k) K223173
K223173 is an FDA 510(k) premarket notification submitted by W&H Dentalwerk Buermoss GmbH for the device "Proxeo ULTRA (PB-510, PB-520 and PB-530)". The FDA issued a decision of Substantially Equivalent on July 14, 2023. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. W&H Dentalwerk Buermoss GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 2023
- Date Received
- October 11, 2022
- 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