Clearance Summary
REIGNING CROWN-BRIDGE/POLYCARB. RESIN received FDA 510(k) clearance under submission number K801237, 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 1980-06-09.
- Submission: K801237
- Applicant / Sponsor: Oki Shiks USA , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 1980-06-09
Classification & Regulation
This clearance is catalogued under FDA product code EBF and 21 CFR 872.3690, within the Dental review panel as a Class II device.