FDA (CDRH)
GUIDANCE FINAL
Dental Curing Lights - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
Published: 9/2/2026Detected: 9/4/2026
Summary preview
Provides FDA’s expectations for 510(k) premarket notification submissions for dental curing lights, clarifying what information and testing should be included to demonstrate substantial equivalence.
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#510(k)
#dental curing light
#substantial equivalence
#performance testing
#labeling
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