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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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Premise Flowable 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 nonstress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.

Premise Flowable is a nano-filled, light-cure, resin restorative material dispensed in a syringe with single-use tips. Premise Flowable uses pre-polymerized filler and nanofillers combined with proven Point 4 technology to deliver strength and durability.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary for a dental restorative material called "Premise Flowable," outlining its intended use, description, and claiming substantial equivalence to predicate devices, but it does not detail specific performance studies or acceptance criteria for those studies.

Ask a specific question about this device