Clearance Summary
ACME COATED ORTHODONTIC ARCHWIRE received FDA 510(k) clearance under submission number K895483, sponsored by Acme-Monaco Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1990-01-29.
- Submission: K895483
- Applicant / Sponsor: Acme-Monaco Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.5410
- Decision date: 1990-01-29
Classification & Regulation
This clearance is catalogued under FDA product code EJF and 21 CFR 872.5410, within the Dental review panel as a Class I device.