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FLOWABLE COMPOSITE is used for: Filling of defects and undercuts in crowns, inlays and onlays; As a liner under direct restorative materials and under inlay restorations-Class II box liner; Tunnel preparations; Pit and fissure sealants; Amalgam* margin repair; Improving margins of acrylic temporaries; Small class IV repairs; Intraoral porcelain repair; Cementing porcelain veneers, crowns, inlays/onlays; Refacing acrylic temporaries; Blockouts: Covering incisal edge stains; Repair of small enamel defects; Provisional occlusal changes; Class III and V restorations; Conservative Class 1 restorations; and Marqin correction/adjustment of composite crowns for indirect laboratory use.

FLOWABLE COMPOSITE is a one-component, moderately filled, visible light cured dental composite restorative material. FLOWABLE COMPOSITE is a low viscosity, esthetic material for use as a composite restorative. It is a moderately filled, radiopaque, fluoride-releasing composite, primarily designed for restoration of shallow defects such as incipient Class V lesions. The physical properties of FLOWABLE COMPOSITE meet ISO Standard 4049.

The provided text is a 510(k) summary for a dental device called "FLOWABLE COMPOSITE." It states that the device's physical properties meet ISO Standard 4049. However, it does not contain any information about acceptance criteria, specific device performance metrics, sample sizes for testing, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.

Therefore, I cannot populate the requested table or answer the specific questions about the study that proves the device meets acceptance criteria. The document explicitly states: "The physical properties of FLOWABLE COMPOSITE meet ISO Standard 4049." This is the only "acceptance criteria" mentioned, and the document claims the device meets it, but provides no further details on how this was proven.

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