Clearance Summary
COLTOLUX LED CURING LIGHT received FDA 510(k) clearance under submission number K040551, 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 2004-03-15.
- Submission: K040551
- Applicant / Sponsor: Coltene/Whaledent, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6070
- Decision date: 2004-03-15
Classification & Regulation
This clearance is catalogued under FDA product code EBZ and 21 CFR 872.6070, within the Dental review panel as a Class II device.