歯科用ｺﾝﾎﾟｼﾞｯﾄﾚｼﾞﾝ/光重合用照射510Kｶﾞｲﾀﾞﾝｽ - Dental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances;

The Food and Drug Administration (FDA or Agency) is announcing the availability of two draft guidances entitled “Dental Composite Resin Devices—Premarket Notification (510(k)) Submissions” and “Dental Curing Lights—Premarket Notification (510(k)) Submissions.” These draft guidance documents provide recommendations for device description, performance testing, and labeling to include in 510(k) submissions for dental composite resin devices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. When final, these guidances will 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 draft guidances are intended to promote consistency and facilitate efficient review of these submissions. These draft guidances are not final nor are they for implementation at this time.

https://www.fda.gov/media/179983/download