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AMARIS/AMARIS FLOW is a light curing, radiopaque composite filling material for both anterior and posterior applications.

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This document is a 510(k) clearance letter from the FDA for a dental filling material named Amaris/Amaris Flow. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. The letter is an administrative notice of clearance, not a technical report or scientific study summary. It merely confirms that the device can be legally marketed based on its substantial equivalence to other devices, but it does not detail performance metrics, study designs, or ground truth establishment.

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

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