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One Coat 7 Universal is indicated for:

• bonding in adhesive restoration techniques
• adhesive attachment of composite materials and compomers on enamel and dentin
• adhesive attachment of ceramic and composite restorations on enamel and dentine
• composite material on ceramic, composite material, metal and amalgam
• dentine sealing

Not Found

The provided document is a 510(k) clearance letter from the FDA for a dental resin bonding agent, "One Coat 7 Universal." This type of document declares substantial equivalence to a predicate device and does not contain information about the acceptance criteria and study data typical for software or AI/ML-driven medical devices.

Therefore, I cannot provide the requested information as the document does not describe:

• Acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy).
• Any study data proving the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone performance.
• Type of ground truth used.
• How ground truth was established for training data.

This letter solely confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements.

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