Clearance Summary
PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER received FDA 510(k) clearance under submission number K904128, 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 1990-11-09.
- Submission: K904128
- Applicant / Sponsor: American Orthodontics
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.5525
- Decision date: 1990-11-09
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.