Clearance Summary
LIGHT CURE DENTAL DAM received FDA 510(k) clearance under submission number K021524, sponsored by Prime Dental Manufacturing, 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 2002-07-19.
- Submission: K021524
- Applicant / Sponsor: Prime Dental Manufacturing, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6300
- Decision date: 2002-07-19
Classification & Regulation
This clearance is catalogued under FDA product code EIE and 21 CFR 872.6300, within the Dental review panel as a Class I device.