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510(k) Data Aggregation

    K Number
    K032136
    Device Name
    WIROBOND C
    Manufacturer
    BEGO U.S.A.
    Date Cleared
    2003-09-04

    (55 days)

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

    WIROBOND C

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

    Wirobond C is a non-Precious dental casting alloy to make full crowns and copings for porcelain fused to metal dental restorations.

    Device Description

    Wirobond C is a non-Precious dental casting alloy.

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a dental alloy, Wirobond C. It does not contain any information about acceptance criteria, device performance studies, or AI/software algorithm assessments.

    Therefore, I cannot provide a response to your request, as the necessary information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details is completely absent from the provided text.

    This document is solely focused on the regulatory clearance of a physical medical device (dental alloy) and confirms its substantial equivalence to a predicate device.

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