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510(k) Data Aggregation

    K Number
    K110050
    Device Name
    FIT TEST C&B
    Manufacturer
    VOCO GMBH
    Date Cleared
    2011-03-28

    (80 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FIT TEST C&B

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

    Fit Test C&B is intended for the following applications: Control of precise fit, marginal tightness and marginal gap of - full or partial crowns - bridges - inlays/onlays - cast post cores/post crowns - metal bases - implant-supported crowns and bridges - attachments and other secondary parts of dentures

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer your request. The document is a letter from the FDA regarding a 510(k) premarket notification for a dental impression material named "Fit Test C&B." It primarily discusses regulatory classification and general controls.

    The document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    Therefore, I cannot extract the information you requested about the study that proves the device meets acceptance criteria.

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