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510(k) Data Aggregation

    K Number
    K023477
    Device Name
    BIOLOY
    Manufacturer
    NEIRYNCK & VOGT NV
    Date Cleared
    2002-12-13

    (58 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIOLOY

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

    Bioloy alloy is intended to be used by dentists and dental laboratories for the fabrication of custom made dental devices such as onlays, ¼ crowns, veneers, inlays and PFM restorations.

    Device Description

    Bioloy

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria.

    The document is a letter from the FDA regarding a 510(k) premarket notification for a device named "Bioloy" (a "Base Metal Alloy"). It states that the device is substantially equivalent to legally marketed predicate devices. It also outlines the indications for use.

    However, this document does not contain any information about:

    • Acceptance criteria for performance (e.g., specific metrics like accuracy, sensitivity, specificity, or mechanical properties).
    • Device performance data showing how Bioloy met any criteria.
    • Details of a study conducted to demonstrate performance (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details).

    This letter is a regulatory filing approval and not a detailed study report.

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