Clearance Summary
DuoCem received FDA 510(k) clearance under submission number K160800, sponsored by Coltene/Whaledent AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2016-11-16.
- Submission: K160800
- Applicant / Sponsor: Coltene/Whaledent AG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 2016-11-16
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.