Clearance Summary
F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND received FDA 510(k) clearance under submission number K920644, sponsored by Fairform Mfg., Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1992-05-29.
- Submission: K920644
- Applicant / Sponsor: Fairform Mfg., Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6865
- Decision date: 1992-05-29
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.