Clearance Summary
DOC'S BEST WHITE COPPER CEMENT received FDA 510(k) clearance under submission number K031494, sponsored by Cooley & Cooley, 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 2003-11-12.
- Submission: K031494
- Applicant / Sponsor: Cooley & Cooley, Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 2003-11-12
Classification & Regulation
This clearance is catalogued under FDA product code EMA and 21 CFR 872.3275, within the Dental review panel as a Class II device.