Clearance Summary
REGENCY BRACKET received FDA 510(k) clearance under submission number K936244, sponsored by Mid-American Dental Specialties, 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 1994-02-02.
- Submission: K936244
- Applicant / Sponsor: Mid-American Dental Specialties, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.5410
- Decision date: 1994-02-02
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.