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510(k) Data Aggregation

    K Number
    K151956
    Device Name
    Admira Fusion x-tra
    Manufacturer
    VOCO GMBH
    Date Cleared
    2015-10-20

    (97 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Admira Fusion x-tra is intended for use as: - Class I and II posterior restorations - Base in class I and II cavities - Class V restorations - Locking, splinting of loose anteriors - Repairing veneers, small enamel defects and temporary C&B-materials - Extended fissure sealing - Restoration of deciduous teeth - Core build-up

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a dental resin material. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Such details would typically be found in the 510(k) submission document itself, not in the clearance letter.

    Therefore, I cannot extract the requested information from the provided text.

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