71bcbe5a-af13-4c3f-9793-6f90f08bd41cNewPublished12024-05-162024-05-08In Commercial DistributionE22190941PrimaryHIBCCCelalux III90949094316699578VOCO GmbH1High-Power LED curing-light (pool)falsefalsefalsefalsefalsefalsetruefalsetruefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse999-999-9999xxx@xx.xx35775Dental/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 PolymerizationStorage Environment Temperaturefalsefalse