Clearance Summary
ALINE ORTHODONTIC ARCHWIRE received FDA 510(k) clearance under submission number K841638, sponsored by A Company, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1984-06-27.
- Submission: K841638
- Applicant / Sponsor: A Company, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.5410
- Decision date: 1984-06-27
Classification & Regulation
This clearance is catalogued under FDA product code DZC and 21 CFR 872.5410, within the Dental review panel as a Class I device.