Dental Composite Resin Devices – Premarket Notification (510(k)) Submissions

FDA is announcing the availability of a final guidance titled "Dental Composite Resin Devices--Premarket Notification (510(k)) Submissions." This guidance provides recommendations for device description, performance testing, and labeling to include in 510(k) submissions for dental composite resin devices. It supersedes the guidance "Dental Composite Resin Devices--Premarket Notification [510(k)] Submissions" dated... The post Dental Composite Resin Devices – Premarket Notification (510(k)) Submissions appeared first on Avance Biosciences .