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510(k) Data Aggregation

    K Number
    K090644
    Device Name
    VITABLOCS, MODEL VX55-****
    Manufacturer
    VITA ZAHNFABRIK H. RAUTER GMBH & CO.
    Date Cleared
    2009-03-31

    (21 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VITABLOCS, MODEL VX55-****

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

    Vitablocs® are indicated for use as a dental restoration including inlays, onlays, veneers and crowns.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for Vitablocs®, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as registration, labeling, and good manufacturing practices, and specifies the indications for use.

    However, it does not include:

    1. A table of acceptance criteria or reported device performance.
    2. Details about sample sizes, data provenance, or ground truth for any studies.
    3. Information about experts, adjudication methods, or MRMC comparative effectiveness studies.
    4. Information about standalone algorithm performance or training sets.

    Therefore, I cannot fulfill your request based on the given input.

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