Clearance Summary
DENTAL LIGHT received FDA 510(k) clearance under submission number K772351, sponsored by Chemetron Dental Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1978-01-17.
- Submission: K772351
- Applicant / Sponsor: Chemetron Dental Products
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4630
- Decision date: 1978-01-17
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.