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 categoryRetainer, Screw Expansion, Orthodontic
Device ID06975527184035
AvailabilityOver the counter
Single useYes
LatexNot made with natural rubber latex
MRI safetyLabeling does not contain MRI Safety Information