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Venus flow is a flowable, light curing, radiopaque hyrbrid composite used for adhesive, tooth-colored anterior and posterior restorations. Due to its low viscosity Venus Flow provides excellent coverage tooth structure.

Applicable applications includes:

Baseliner in Class I & II cavities; Fissure sealing; Enlarged fissure sealing; Class V fillings; Minimally invasive Class I and II fillings in areas not subjected to masticatory forces; Minimally invasive Class III fillings; Smaller contour and shade adjustment on the enamel and dentine; Small surface repairs to direct and indirect restorative in combination with a suitable bonding agent; Splinting teeth; Cavity lining; Bracket retention; Sealing endodontically treated teeth; Luting porcelain or composite veneers; Filling in voids in temporary crown and bridges materials

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The provided document is a 510(k) clearance letter from the FDA for a dental resin material named "Venus™ Flow." It is a regulatory document confirming substantial equivalence to a predicate device and permits marketing. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

Therefore, I cannot provide a description of acceptance criteria or a study based on the input document. The document primarily focuses on regulatory approval, not device performance data.

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