Clearance Summary
REIGNING DENTURE received FDA 510(k) clearance under submission number K821217, sponsored by Oki Shiks USA , 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 1982-06-07.
- Submission: K821217
- Applicant / Sponsor: Oki Shiks USA , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3760
- Decision date: 1982-06-07
Classification & Regulation
This clearance is catalogued under FDA product code EBI and 21 CFR 872.3760, within the Dental review panel as a Class II device.