Device typeDental appliance fabrication material, resin: A 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.
FDA categoryMouthguard, prescription, POSITIONER, TOOTH, PREFORMED
Device IDH66842001611
Catalog number4200161
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information
Total Volume17.6 Fluid Ounce
Weight0.5 Kilogram