Clearance Summary
EASY CURING PEN-STYLE LED CURING LIGHT received FDA 510(k) clearance under submission number K063659, sponsored by Dent Corp. Research & Development. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2007-04-30.
- Submission: K063659
- Applicant / Sponsor: Dent Corp. Research & Development
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6070
- Decision date: 2007-04-30
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.