Clearance Summary
BRITESMILE MASKING CREAM received FDA 510(k) clearance under submission number K040797, sponsored by Britesmile, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2004-04-02.
- Submission: K040797
- Applicant / Sponsor: Britesmile, Inc.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6300
- Decision date: 2004-04-02
Classification & Regulation
This clearance is catalogued under FDA product code EIE and 21 CFR 872.6300, within the Dental review panel as a Class I device.