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GUIDANCE DOCUMENT

Dental Curing Lights - Premarket Notification (510(k)) Submissions Draft Guidance for Industry and Food and Drug Administration Staff July 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-2512
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance document provides the FDA’s recommendations on device description, performance testing, and labeling to support premarket submissions for dental curing light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.

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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-2024-D-2512 .

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