ae881e1b-8862-443c-849b-f25e27d70a07UpdatePublished32018-07-062016-08-01In Commercial DistributionD805500501LNZ2522PrimaryHIBCCD805500501LNZ2520Unit of UseHIBCCiFlex by TCS5005-01/LNZ25-25005-01/LNZ25-2808897776THERMOPLASTIC COMFORT SYS5iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates for removable dental prosthetic appliances. This includes but is not to be limited to full and partial removable dentures, orthodontics devices, occlusal splints, and night guards.falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse562-426-2970info@tcsdentalinc.comK12339600058288Dental 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.falseActiveEBIResin, Denture, Relining, Repairing, RebasingMQCMouthguard, Prescriptionfalsefalse