Dental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances; Guidances for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of two final guidances titled "Dental Composite Resin Devices--Premarket Notification (510(k)) Submissions" and "Dental Curing Lights--Premarket Notification (510(k)) Submissions." These guidance documents provide recommendations for device description, performance testing, and labeling to include in 510(k) submissions for dental composite resin devices and dental curing lights. These guidances supersede the guidances "Dental Composite Resin Devices-- Premarket Notification [510(k)] Submissions" dated October 26, 2005 and "Dental Curing Lights--Premarket Notification [510(k)] Submissions" dated March 27, 2006. The recommendations in these guidances are intended to promote consistency and facilitate efficient review of these submissions.

Source: Federal Register (FDA/USDA food labeling) · US Government work (public domain). This is a short, attributed summary; the full authoritative text lives on the authority’s own site. LabelYog does not author or endorse it — confirm compliance against the destination market’s official source.

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