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Restoration of deciduous teeth (especially class I) cavities

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The provided text is an FDA 510(k) clearance letter for a dental cement, "Ionofil Color AC". This type of document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The letter's purpose is to inform the manufacturer that their device has been found substantially equivalent to a legally marketed predicate device, allowing them to market it. It discusses regulatory classifications, general controls, and compliance requirements, but not the technical details of the device's performance validation.

Therefore, I cannot provide the requested information based on the given text.

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