Clearance Summary
PREFORMED TEMPLATE FOR TOOTH POSITIONER received FDA 510(k) clearance under submission number K891328, sponsored by American Orthodontics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1989-03-31.
- Submission: K891328
- Applicant / Sponsor: American Orthodontics
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.5525
- Decision date: 1989-03-31
Classification & Regulation
This clearance is catalogued under FDA product code KMY and 21 CFR 872.5525, within the Dental review panel as a Class I device.