Clearance Summary
BIOSONIC ULTRASONIC SCALER SYSTEM received FDA 510(k) clearance under submission number K983727, sponsored by Coltene/Whaledent, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1999-01-20.
- Submission: K983727
- Applicant / Sponsor: Coltene/Whaledent, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4850
- Decision date: 1999-01-20
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.