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510(k) Data Aggregation

    K Number
    K083438
    Device Name
    BIFIX SE
    Manufacturer
    VOCO GMBH
    Date Cleared
    2009-02-13

    (85 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Bifix SE is intended for the following applications:

    • permanent luting of inlays, onlays, crowns and bridges made from ceramic, composite and/or metal
    • permanent luting of metal, ceramic and fibre-reinforced posts
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental cement (Bifix SE). It does not contain information about acceptance criteria, device performance from a study, sample sizes, expert qualifications, or details about a study design (MRMC, standalone, etc.) for an AI device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given document.

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