Clearance Summary
Proxeo ULTRA (PB-510, PB-520 and PB-530) received FDA 510(k) clearance under submission number K223173, sponsored by W&H Dentalwerk Buermoss GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2023-07-14.
- Submission: K223173
- Applicant / Sponsor: W&H Dentalwerk Buermoss GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4850
- Decision date: 2023-07-14
Classification & Regulation
This clearance is catalogued under FDA product code ELC and 21 CFR 872.4850, within the Dental review panel as a Class II device.