Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions Guidance

The FDA's updated guidance assists industry in preparing premarket notification submissions (510(k)s) for dental composite resin devices, reflecting current review practices and aiming to facilitate consistent submission reviews.

What changed: The FDA has released a final guidance document on September 2, 2026, outlining comprehensive recommendations for device description, non-clinical and clinical performance testing, and labeling for dental composite resin devices.

Why it matters: This guidance is critical for manufacturers of dental composite resin devices as it establishes the standards and expectations for regulatory submissions, impacting compliance and market access.

Practical implication: Companies preparing 510(k) submissions for dental composite resin devices must align with the recommendations specified in the new guidance, which include detailed testing and labeling criteria.

• Recalls, Market Withdrawals and Safety Alerts
• Warning Letters
• Safety
• Inspections and Compliance
• Download the Final Guidance Document

• Dental Composite Resin Devices - Premarket Notification (510(k ... - FDA
• Dental Composite Resin Devices - Guidance for Industry and FDA Staff
• Premarket Notification (510(k)) Submissions: Draft Guidance for ...

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• Source: FDA - Regulatory Information
• Published at source: 2026-09-01T00:00:00.000Z
• Discovered by monitor: 2026-09-01T22:08:08.426Z

Published from the regulator source ingestion pipeline after PV impact triage.