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510(k) Data Aggregation

    K Number
    K013929
    Device Name
    HELIOMOLAR HB TRANSLUCENT SHADES
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2002-02-07

    (71 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

    Heliomolar HB is a light-curing, radiopaque microfilled composite specifically designed for posterior restorations. The Translucent shades are to be used as a top lor the restoration to further enhance the esthetic appearance.

    Device Description

    Heliomolar HB is a light-curing, radiopaque microfilled composite specifically designed for posterior restorations. The Translucent shades are to be used as a top lor the restoration to further enhance the esthetic appearance.

    AI/ML Overview

    The provided text is a set of FDA correspondence letters and a form. It does not contain any information about acceptance criteria, study details, device performance, sample sizes, ground truth establishment, or expert qualifications for a medical device.

    The document is a 510(k) premarket notification letter for a dental composite filling material, "Heliomolar HB Translucent Shades" (K013929). It confirms that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details from the provided text.

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