Clearance Summary
Keymill received FDA 510(k) clearance under submission number K172764, sponsored by Mycone Dental Supply Company, Inc. (Aka 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 2018-04-27.
- Submission: K172764
- Applicant / Sponsor: Mycone Dental Supply Company, Inc. (Aka Keystone Industries)
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3760
- Decision date: 2018-04-27
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.