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Ketac-Molar® Aplicap® is a glass ionomer cement material indicated for the following uses: (1) linings for Class I and II cavities filled with composite; (2) core build-ups; (3) fillings in deciduous teeth; (4) fillings in Class I cavities located in non-occlusal load bearing areas; (5) fillings in Class V cavities if the aesthetics are not of primary importance; and (6) temporary fillings in Class I and II cavities.

slightly modified glass ionomer cement material, referred to by the tradename Ketac-Molar Aplicap®. The reason for this modification is to provide for an improved compressive strength.

This document describes a 510(k) premarket notification for modifications to a dental cement material (Ketac-Molar Aplicap®), focusing on improved compressive strength. The request is to identify acceptance criteria and study details. However, the provided text does not contain information about acceptance criteria or a study with performance results relevant to the specified questions.

The document states: "Ketac-Molar® Aplicap® meets the requirements of relevant DIN and ISO standards for dental cement." This indicates that the product adheres to general dental cement standards, but it doesn't provide specific quantitative acceptance criteria or a study detailing device performance against those criteria in the format requested.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document focuses on the reason for modification (improved compressive strength) and claims substantial equivalence based on physical and technical characteristics and water-soluble fluoride content compared to predicate devices, and adherence to standards, but not a detailed study report with performance metrics.

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