Clearance Summary
MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology received FDA 510(k) clearance under submission number K160825, sponsored by Dentsply Sirona. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2016-09-27.
- Submission: K160825
- Applicant / Sponsor: Dentsply Sirona
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2016-09-27
Classification & Regulation
This clearance is catalogued under FDA product code EKX and 21 CFR 872.4200, within the Dental review panel as a Class I device.