Clearance Summary
A-COMPANY STAINLESS STEEL ORTHODONTIC BRACKETS received FDA 510(k) clearance under submission number K851454, 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 1985-04-29.
- Submission: K851454
- Applicant / Sponsor: A Company, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1985-04-29
Classification & Regulation
This clearance is catalogued under FDA product code ECQ and 21 CFR 872.4565, within the Dental review panel as a Class I device.