Issue Date: March 27, 2006
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Dental
Status: Final
Dental Curing Lights – Premarket Notification [510(k)]: Guidance for Industry and FDA Staff
FDA has developed this guidance document to assist industry in preparing premarket notification submissions for dental curing lights intended for polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod (21 CFR 872.6070).
Download the Guidance Document
