The U.S. Food and Drug Administration (FDA) finalized two guidance documents covering 510(k) premarket notification submissions for dental composite resin devices and dental curing lights, according to a notice published September 2 in the Federal Register.
The guidances outline recommendations for device description, performance testing, and labeling in 510(k) submissions. They replace guidance documents dated 2005 and 2006, respectively.
For curing lights, the finalized guidance specifies that manufacturers measure radiant power output at the device tip rather than 2 mm from it, and it removes resin depth-of-cure measurement requirements that appeared in the draft version. The FDA noted the recommendations reflect its current thinking and are not legally binding; manufacturers may use alternative approaches that satisfy applicable regulations.
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