d31c2950-af28-4f24-835a-f75390007ad1UpdatePublished32025-10-312023-08-29In Commercial DistributionEPRCD1001501PrimaryHIBCCprintodent GR-19.1 OAclear-transparent, 1000gD1001501312947842pro3dure medical GmbH1falsefalsefalsefalsefalsefalsetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK23177500016730Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.falseActiveMQCMouthguard, Prescriptionfalsefalse