f06ad125-ad2b-4510-a3c1-68cf93f75432NewPublished12024-11-252024-11-17In Commercial DistributionJ01833481PrimaryHIBCCJ01833480Unit of UseHIBCCDURASOFT® blue pd3348.1317683787Scheu-Dental GmbH10DURASOFT® blue pd 2.5 x 125 mm, hard / soft: 1.6 mm / 0.9 mmfalsetruefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse58288Dental appliance fabrication material, thermoplasticA thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.falseActiveKMYPositioner, Tooth, PreformedStorage Environment Temperaturefalsefalse