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510(k) Data Aggregation

    K Number
    K973924
    Device Name
    FRIOS BONESHIELD
    Manufacturer
    FRIATEC AG
    Date Cleared
    1998-05-07

    (204 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FRIOS BONESHIELD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Friatec Bone Shield is indicated for use for insuring three dimensional alveolar bone defects and Facilitating augmentation with adequate fixation of the augmentation material.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth.

    The document is a 510(k) clearance letter from the FDA to FRIATEC AG for their device called "Frios Boneshield." It states that the device is substantially equivalent to legally marketed predicate devices and outlines the general controls and regulations applicable to the device. The "Indications For Use" provided describe the purpose of the device (insuring three-dimensional alveolar bone defects and facilitating augmentation), but not its performance metrics or acceptance criteria from a study.

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