Clearance Summary
BATTERY-POWERED TOOTHBRUSH received FDA 510(k) clearance under submission number K904401, sponsored by The B & F System, 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 1990-12-07.
- Submission: K904401
- Applicant / Sponsor: The B & F System, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6865
- Decision date: 1990-12-07
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.