federal_register: 2013-02688

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2013-02688 Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis Proposed Rule The Food and Drug Administration (FDA) is issuing a proposed 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 draft special controls guideline, "Class II Special Controls Guideline: Temporary Mandibular Condyle Reconstruction Plate," which sets forth the special controls that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the device. 2013-02-07 2013 2 https://www.federalregister.gov/documents/2013/02/07/2013-02688/dental-devices-reclassification-of-temporary-mandibular-condyle-prosthesis https://www.govinfo.gov/content/pkg/FR-2013-02-07/pdf/2013-02688.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is issuing a proposed 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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