Clearance Summary
One Coat 7 Universal received FDA 510(k) clearance under submission number K152243, 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 2015-12-09.
- Submission: K152243
- Applicant / Sponsor: Coltene/Whaledent AG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3200
- Decision date: 2015-12-09
Classification & Regulation
This clearance is catalogued under FDA product code KLE and 21 CFR 872.3200, within the Dental review panel as a Class II device.