Clearance Summary
IMPROVED DENTAL OPERATING LIGHT received FDA 510(k) clearance under submission number K920017, sponsored by Den-Tal-Ez Mfg Co., 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 1992-03-02.
- Submission: K920017
- Applicant / Sponsor: Den-Tal-Ez Mfg Co., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6250
- Decision date: 1992-03-02
Classification & Regulation
This clearance is catalogued under FDA product code KLC and 21 CFR 872.6250, within the Dental review panel as a Class I device.