Dental devices; reclassification of temporary mandibular condyle prosthesis. Final order

The Food and Drug Administration (FDA) is issuing a final order to reclassify temporary mandibular condyle prosthesis, a preamendments class III device, into class II (special controls), and rename the device "temporary mandibular condyle reconstruction plate.'' FDA is also issuing the special controls guideline entitled "Temporary Mandibular Condyle Reconstruction Plate Class II Special Controls Guideline'' that sets forth the special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the device.