Clearance Summary
ORTHODONTIC BRACKET/SPEED/HANSON SPEED received FDA 510(k) clearance under submission number K801809, sponsored by Strite Industries , 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 1980-08-13.
- Submission: K801809
- Applicant / Sponsor: Strite Industries , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.5410
- Decision date: 1980-08-13
Classification & Regulation
This clearance is catalogued under FDA product code EJF and 21 CFR 872.5410, within the Dental review panel as a Class I device.