Clearance Summary
COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC received FDA 510(k) clearance under submission number K912485, sponsored by Coltene/Whaledent, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1991-07-25.
- Submission: K912485
- Applicant / Sponsor: Coltene/Whaledent, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 1991-07-25
Classification & Regulation
This clearance is catalogued under FDA product code ELW and 21 CFR 872.3660, within the Dental review panel as a Class II device.