Clearance Summary
ORAL SAFE received FDA 510(k) clearance under submission number K832359, sponsored by Great Lakes Orthodontics, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1983-09-26.
- Submission: K832359
- Applicant / Sponsor: Great Lakes Orthodontics, Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3530
- Decision date: 1983-09-26
Classification & Regulation
This clearance is catalogued under FDA product code JER and 21 CFR 872.3530, within the Dental review panel as a Class I device.