# Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions:  Guidance for Industry and Food and Drug Administration Staff  - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/dental-composite-resin-devices-premarket-notification-510k-submissions-guidance-for-industry-and-food-and-drug-administration-staff/60dc250e-84b6-4013-b5e2-9d1679fe3482

> FDA guidance document: Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions:  Guidance for Industry and Food and Drug Administration Staff . Issue date: September 02, 2026. Get complete insights and analysis.

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## Details

- Title: Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions:  Guidance for Industry and Food and Drug Administration Staff 
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2026-09-02
- Last Changed: 2026-09-01
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2024-D-2511">FDA-2024-D-2511</a>

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