Clearance Summary
NICKLE-TITANIUM ORTHODONTIC WIRE received FDA 510(k) clearance under submission number K891327, sponsored by American Orthodontics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1989-05-10.
- Submission: K891327
- Applicant / Sponsor: American Orthodontics
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1989-05-10
Classification & Regulation
This clearance is catalogued under FDA product code FJF and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.