d9803ea5-d315-4702-9ad2-2478bca78428UpdatePublished22018-03-292016-08-16In Commercial DistributionD661600185141PrimaryHIBCCD661600185140Unit of UseHIBCCSPEC 360018514622185718COLTENE/WHALEDENT INC5SPEC 3 Tracking TipfalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationfalsefalse3309168800info.us@coltene.com35775Dental/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 PolymerizationfalsetrueMoist Heat or Steam Sterilization