Clearance Summary
DEN-MAT FIBER OPTIC HALOGEN LIGHT received FDA 510(k) clearance under submission number K802716, sponsored by Den-Mat Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1980-11-12.
- Submission: K802716
- Applicant / Sponsor: Den-Mat Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4620
- Decision date: 1980-11-12
Classification & Regulation
This clearance is catalogued under FDA product code EAY and 21 CFR 872.4620, within the Dental review panel as a Class I device.