Federal Register #FDA-2024-D-2511 and FDA-2024-D-2512

FDA Guidance for Dental Composite Resin Devices and Dental Curing Lights 510(k) Submissions

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has issued final guidance documents for manufacturers submitting 510(k) premarket notifications for dental composite resin devices and dental curing lights. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Guidance Documents Released: - 'Dental Composite Resin Devices--Premarket Notification (510(k)) Submissions' - 'Dental Curing Lights--Premarket Notification (510(k)) Submissions' - Purpose: - Provide recommendations for device description, performance testing, and labeling - Supersede previous guidances from 2005 and 2006 - Promote consistency and facilitate efficient review of submissions - Notable Requirements: - No specific OEMs, vendors, products, part numbers, or purchase quantities are mentioned - Notice is informational, intended to assist industry and FDA staff in regulatory submission process - OEMs: - No OEMs or vendors specified in the guidance - Products/Services: - No products or services requested; guidance pertains to regulatory submission process

Description

The Food and Drug Administration (FDA) has announced 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 guidances provide recommendations for device description, performance testing, and labeling for 510(k) submissions related to dental composite resin devices and dental curing lights. They supersede previous guidances from 2005 and 2006, aiming to promote consistency and facilitate review of submissions. The guidances are intended to assist industry and FDA staff in the review and submission process for these dental devices.

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