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510(k) Data Aggregation

    K Number
    K031484
    Device Name
    STAND OUT
    Manufacturer
    KERR CORP.
    Date Cleared
    2003-07-03

    (52 days)

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

    STAND OUT

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

    Stand Out is an addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous and implant impression techniques.

    Device Description

    The device is an addition-cure vinyl polysiloxane dental impression material that is used for all crowns and bridges, edentulous and implant impression techniques. Stand Out is a two-part, base/catalyst - paste/paste system. The product is available in two viscosities, Wash and Tray.

    AI/ML Overview

    The provided text is a 510(k) Summary of Safety and Effectiveness for a dental impression material named "Stand Out." It contains information about the device's name, common name, classification, predicate devices, device description, and intended use. However, it does not include any information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical studies (such as MRMC or standalone studies).

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document focuses on regulatory submission for substantial equivalence rather than reporting detailed study results or performance metrics.

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