Dental Curing Lights – Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff

Issue Date: July 12, 2024
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Dental
Status: Draft

Dental Curing Lights – Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff

This draft guidance document provides the FDA’s recommendations on device description, performance testing, and labeling to support premarket submissions for dental curing light devices. The recommendations are intended to promote consistency and facilitate efficient review of dental curing light submissions.

Download the Guidance Document