Clearance Summary
DENTAL LIGHT received FDA 510(k) clearance under submission number K926081, sponsored by Mdt Corp., 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 1994-01-26.
- Submission: K926081
- Applicant / Sponsor: Mdt Corp., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4630
- Decision date: 1994-01-26
Classification & Regulation
This clearance is catalogued under FDA product code EAZ and 21 CFR 872.4630, within the Dental review panel as a Class I device.