Device typeDental appliance fabrication material, thermoplastic: A 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.
FDA categoryMouthguard, Prescription
Device IDD7091019081
Catalog number1019081
MRI safetyLabeling does not contain MRI Safety Information
Outer Diameter98.5 Millimeter
Height20 Millimeter