Clearance Summary
REFURBISHED ORTHODONTIC APPLIANCES received FDA 510(k) clearance under submission number K913913, sponsored by Ortho-Cycle Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1991-11-27.
- Submission: K913913
- Applicant / Sponsor: Ortho-Cycle Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.5410
- Decision date: 1991-11-27
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.