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Intended Use: Ariston pHc Liner is intended to be used as an adhesive for direct light curing composite and compomer restorations.

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This is an FDA 510(k) clearance letter for the Ariston pHc Liner and does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter acknowledges that the device is substantially equivalent to a legally marketed predicate device for its stated indications for use.

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Intended Use: Ariston pHc filling material is intended to be used for Intended USE. Allscon pho firming indeciduous and permanent teeth with Crass I and if reparations and for an amalgam substitute.

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I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a dental filling material called "Ariston pHc", indicating it has been found substantially equivalent to a predicate device.

The letter mentions the device's intended use and regulatory classification, but it does not detail specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement for a performance study.

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