Clearance Summary
SOWELL NICKEL-CHROME NON-PRECIOUS METAL ALLOY received FDA 510(k) clearance under submission number K973568, sponsored by C.K. International Trading. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1997-12-11.
- Submission: K973568
- Applicant / Sponsor: C.K. International Trading
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3710
- Decision date: 1997-12-11
Classification & Regulation
This clearance is catalogued under FDA product code EJH and 21 CFR 872.3710, within the Dental review panel as a Class II device.