{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of two final guidances titled \"Dental Composite Resin Devices--Premarket Notification (510(k)) Submissions\" and \"Dental Curing Lights--Premarket Notification (510(k)) Submissions.\" These guidance documents provide recommendations for device description, performance testing, and labeling to include in 510(k) submissions for dental composite resin devices and dental curing lights. These guidances supersede the guidances \"Dental Composite Resin Devices-- Premarket Notification [510(k)] Submissions\" dated October 26, 2005 and \"Dental Curing Lights--Premarket Notification [510(k)] Submissions\" dated March 27, 2006. The recommendations in these guidances are intended to promote consistency and facilitate efficient review of these submissions.","action":"Notice of availability.","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/2026/09/02/2026-17933.html","cfr_references":[],"citation":"91 FR 56452","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on September 2, 2026.","disposition_notes":null,"docket_ids":["Docket Nos. FDA-2024-D-2511 and FDA-2024-D-2512"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-09-02","updated_at":"2026-09-02T09:56:58.485-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-D-2511-0006","allow_late_comments":false,"id":"FDA-2024-D-2511-0006","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-D-2511","title":"Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-09-02","updated_at":"2026-09-02T10:56:55.610-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-D-2512-0006","allow_late_comments":false,"id":"FDA-2024-D-2512-0006","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-D-2512","title":"Dental Curing Lights - Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability"}],"document_number":"2026-17933","effective_on":null,"end_page":56454,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/09/02/2026-17933.xml","html_url":"https://www.federalregister.gov/documents/2026/09/02/2026-17933/dental-composite-resin-devices-and-dental-curing-lights-premarket-notification-510k-submissions","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-17933?publication_date=2026-09-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-09-02/2026-17933/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1033,"last_updated":"2026-10-22 16:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-02/pdf/2026-17933.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17933.pdf?1788266710","publication_date":"2026-09-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/09/02/2026-17933.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2024-D-2511","supporting_documents_count":0,"docket_id":"FDA-2024-D-2511","document_id":"FDA-2024-D-2511-0006","regulation_id_number":null,"title":"Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2026-09-03T17:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":56452,"subtype":null,"title":"Dental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances; Guidances for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Dental Composite Resin Devices and Dental Curing LightsPremarket Notification (510(k)) Submissions","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}