Clearance Summary
BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101 received FDA 510(k) clearance under submission number K063704, sponsored by Beks Incorporated. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2007-02-20.
- Submission: K063704
- Applicant / Sponsor: Beks Incorporated
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6475
- Decision date: 2007-02-20
Classification & Regulation
This clearance is catalogued under FDA product code EEG and 21 CFR 872.6475, within the Dental review panel as a Class I device.