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Premise Flowable Modified is a nano-filled, light cure, resin dental restorative suitable for Class I - V restorations. Additional functions include: base/liner material, repair of enamel defects, repair of temporaries, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing area, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions and core build-ups.

Premise Flowable Modified is a medium viscosity, light-cured, nano filled, resin restorative material, dispensed in a syringe with single-use tips. It is suitable for Class I - V restorations. This nano composite technology incorporates three different fillers resulting in a flowable, yet sculptable and non-slumping material.

The provided text is a 510(k) summary for a dental restorative material. It does not contain information about acceptance criteria, device performance metrics, or any studies involving a test set, expert ground truth, or human-AI comparison.

The document discusses the device's name, description, intended use, and claims of substantial equivalence to a legally marketed predicate device (Premise Flowable by Kerr Corporation). It also includes the FDA's clearance letter.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and a study proving the device meets them, as that information is not present in the provided text. This document is a regulatory submission summary, not a scientific study report.

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