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• filling minimally invasive cavities of all classes
• filling small class I cavities and extended fissure sealing
• filling class II-V cavities including V-shaped defects and cervical caries -
• blocking out undercuts -
• lining or coating cavities
• repairing fillings and veneers .
• luting translucent prosthetic pieces (e.g. full ceramic crowns, etc.) -

Not Found

The provided document is an FDA 510(k) clearance letter for a dental material (N-Hybrid-Composite LC Flow). It does not contain information about acceptance criteria, study details, or performance data in the context of an AI/ML device. Therefore, I cannot extract the requested information.

The document primarily focuses on:

• Confirming that the device is substantially equivalent to a predicate device.
• Listing the indications for use of the dental composite material.
• Emphasizing compliance with FDA regulations for medical devices.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a 510(k) submission document that details the performance testing of an AI/ML device.

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