Clearance Summary
KELES FACEMASK received FDA 510(k) clearance under submission number K041718, sponsored by Great Lakes Orthodontics, 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 2004-10-15.
- Submission: K041718
- Applicant / Sponsor: Great Lakes Orthodontics, Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5500
- Decision date: 2004-10-15
Classification & Regulation
This clearance is catalogued under FDA product code DZB and 21 CFR 872.5500, within the Dental review panel as a Class II device.