e4cb2639-48c3-4094-8db0-3fe9c2ffd341UpdatePublished32018-07-062016-06-17In Commercial DistributionD661C79451PrimaryHIBCCD661C79450Unit of UseHIBCCColtoluxC7945622185718COLTENE/WHALEDENT INC100100 LIGHT SHIELDS, 13 mm falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationfalsefalse3309168800info.us@coltene.comK04055100035775Dental/surgical polymerization lampA mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station.falseActiveEBZActivator, Ultraviolet, For PolymerizationLumen/Inner DiameterfalsetrueMoist Heat or Steam Sterilization