0e7a70df-37fb-47ea-9c3a-c540aa92825cUpdatePublished42018-11-162016-12-232018-09-30Not in Commercial DistributionD8026477380PrimaryHIBCCZirlux FC2647738647738047019725ARDENT, INC.1falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse16187Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.falseActiveEIHPOWDER, PORCELAINfalsefalse