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510(k) Data Aggregation

    K Number
    K072622
    Device Name
    STANDOUT 2
    Manufacturer
    KERR CORP.
    Date Cleared
    2007-12-04

    (78 days)

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

    STANDOUT 2

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

    StandOut 2 is an impression material system intended for use on all crown and bridge, edentulous, orthodontic and implant impressions.

    Device Description

    StandOut 2 is a dental impression material system that is suitable for all crown and bridge, edentulous, orthodontic and impressions StandOut2 is a two-part, base/catalyst -paste/paste system. The product is available in two viscosities, Wash and Tray.

    AI/ML Overview

    This 510(k) summary for K072622 describes a dental impression material (StandOut 2) and asserts its substantial equivalence to a predicate device (StandOut). The provided document does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria.

    Instead, it focuses on the administrative process of 510(k) clearance, device description, intended use, and substantial equivalence to a legally marketed predicate device.

    Therefore, I cannot provide a response with the requested information as it is not present in the provided text. The document does not describe performance testing against specific acceptance criteria.

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