Clearance Summary
RETAINER, SCREW EXPANSION ORTHODONTIC received FDA 510(k) clearance under submission number K903498, sponsored by Masel Industries, 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 1991-03-12.
- Submission: K903498
- Applicant / Sponsor: Masel Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.5410
- Decision date: 1991-03-12
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.