Clearance Summary
QUICKSMILE received FDA 510(k) clearance under submission number K052040, sponsored by Cosmetic Dental Materials, 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 2005-10-18.
- Submission: K052040
- Applicant / Sponsor: Cosmetic Dental Materials, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6475
- Decision date: 2005-10-18
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.