federal_register: 2013-31217

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2013-31217 Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis Rule 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. 2013-12-30 2013 12 https://www.federalregister.gov/documents/2013/12/30/2013-31217/dental-devices-reclassification-of-temporary-mandibular-condyle-prosthesis https://www.govinfo.gov/content/pkg/FR-2013-12-30/pdf/2013-31217.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...

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