Clearance Summary
ORTHODONTIC HEADGEAR received FDA 510(k) clearance under submission number K912682, sponsored by K-Tek Orthodontic Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1991-12-09.
- Submission: K912682
- Applicant / Sponsor: K-Tek Orthodontic Products
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5500
- Decision date: 1991-12-09
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.