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USFDA Med Dev Guidance: Premarket Notification (510(k)) Submissions - Dental Composite Resin Devices & Dental Curing Lights
Dental restorative materials and curing devices are important components of modern dentistry, and their safety and performance must be demonstrated before marketing. The U.S. Food and Drug Administration (FDA) has issued guidance documents describing recommendations for premarket notification (510(k)) submissions for dental composite resin devices and dental curing lights. The two guidance documents provide device-specific recommendations covering device description, predicat
Sharan Murugan
Sep 54 min read
USFDA Medical Device: Guidance on Dental Products (Dental Impression Materials, Dental Ceramics, Dental Cements and Air Powered Dental Handpieces and Air Motors)
USFDA's Center for Devices and Radiological Health has released four final guidances about dental products, such as Dental Impression...
Sharan Murugan
Sep 28, 20242 min read