Clearance Summary
ClearMet received FDA 510(k) clearance under submission number K152051, sponsored by Mycone Dental Supply Co., T/A Keystone Industries. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2016-03-22.
- Submission: K152051
- Applicant / Sponsor: Mycone Dental Supply Co., T/A Keystone Industries
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3760
- Decision date: 2016-03-22
Classification & Regulation
This clearance is catalogued under FDA product code EBI and 21 CFR 872.3760, within the Dental review panel as a Class II device.