Clearance Summary
ARGI-SATIN OR OPTI0-STAR received FDA 510(k) clearance under submission number K965216, sponsored by Argen Precious Metals, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1997-02-27.
- Submission: K965216
- Applicant / Sponsor: Argen Precious Metals, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3920
- Decision date: 1997-02-27
Classification & Regulation
This clearance is catalogued under FDA product code ELL and 21 CFR 872.3920, within the Dental review panel as a Class II device.