Clearance Summary
REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN received FDA 510(k) clearance under submission number K801235, 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 1980-06-20.
- Submission: K801235
- Applicant / Sponsor: Oki Shiks USA , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3590
- Decision date: 1980-06-20
Classification & Regulation
This clearance is catalogued under FDA product code ELM and 21 CFR 872.3590, within the Dental review panel as a Class II device.