Dental Curing Lights - Premarket Notification [510(k)]
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).
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.