Clearance Summary
BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER received FDA 510(k) clearance under submission number K130137, sponsored by Coltene/Whaledent. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2013-08-23.
- Submission: K130137
- Applicant / Sponsor: Coltene/Whaledent
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4850
- Decision date: 2013-08-23
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.