Clearance Summary
ULTRASONIC TOOTHBRUSH received FDA 510(k) clearance under submission number K820537, sponsored by Ultrasonic Plaque Control Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1982-04-27.
- Submission: K820537
- Applicant / Sponsor: Ultrasonic Plaque Control Laboratories
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6865
- Decision date: 1982-04-27
Classification & Regulation
This clearance is catalogued under FDA product code JEQ and 21 CFR 872.6865, within the Dental review panel as a Class I device.