Clearance Summary
SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM received FDA 510(k) clearance under submission number K100401, sponsored by Hu-Friedy Mfg. Co., 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 2010-03-30.
- Submission: K100401
- Applicant / Sponsor: Hu-Friedy Mfg. Co., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4850
- Decision date: 2010-03-30
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.