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    K Number
    K983081
    Device Name
    BEGOPAL 300
    Manufacturer
    BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO
    Date Cleared
    1998-10-28

    (56 days)

    Product Code
    EJS
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BEGOPAL 300

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

    BegoPal 300 is a crown and bridge metal to ceramic type 4 alloy. It is a medical device in accordance with Regulation 93/42 EEG. Class IIa according to Annex IX. The CE seal is a declaration by the manufacturer that the regulation requirements are met.

    Device Description

    BegoPal 300 is a crown and bridge metal to ceramic type 4 alloy.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental alloy called "BegoPal 300". It states that the device is substantially equivalent to legally marketed predicate devices and is classified as a Class II medical device.

    However, this document does not contain any information about acceptance criteria, device performance, a specific study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established. It is purely a regulatory approval document.

    Therefore, I cannot fulfill your request for the detailed description of acceptance criteria and the study proving device performance based on the provided input.

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