{"abstract":"The Food and Drug Administration (FDA) is proposing to reclassify tricalcium phosphate (TCP) granules for dental bone repair from class III to class II (special controls); classify into class II (special controls) all other bone grafting material for dental indications, except those that contain drug or biologic components; and revise the classification name and identification of the device. Bone grafting materials that contain a drug or biologic component would remain in class III. The proposed classification identification includes materials such as hydroxyapatite, demineralized bone additives, collagen, and polylactic acids. After considering public comments on the proposed reclassification and classification, FDA will publish a final regulation, if appropriate. This action is being taken to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of this device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a draft guidance document that the agency proposes to use as a special control for the device.","action":"Proposed rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2004/06/30/04-14767.html","cfr_references":[{"chapter":null,"citation_url":null,"part":872,"title":21}],"citation":"69 FR 39377","comment_url":null,"comments_close_on":"2004-09-28","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments by September 28, 2004. See section VI of this document for the proposed effective date of a final rule based on this document.","disposition_notes":null,"docket_ids":["Docket No. 2002P-0520"],"dockets":[],"document_number":"04-14767","effective_on":null,"end_page":39380,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2004/06/30/04-14767.xml","html_url":"https://www.federalregister.gov/documents/2004/06/30/04-14767/dental-devices-tricalcium-phosphate-granules-and-other-bone-grafting-material-for-dental-bone-repair","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/04-14767?publication_date=2004-06-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2004-06-30/04-14767/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":182,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2004-06-30/pdf/04-14767.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2004-06-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2004/06/30/04-14767.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T12:37:30Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":39377,"subtype":null,"title":"Dental Devices; Tricalcium Phosphate Granules and Other Bone Grafting Material for Dental Bone Repair","toc_doc":"Tricalcium phosphate granules and other bone grafting material for dental bone repair","toc_subject":"Medical devices:","topics":[],"type":"Proposed Rule","volume":69}