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GUIDANCE DOCUMENT

Dental Curing Lights - Premarket Notification [510(k)] Guidance for Industry and FDA Staff March 2006

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-0957.

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