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510(k) Data Aggregation

    K Number
    K013237
    Device Name
    STATUSBLUE
    Manufacturer
    DMG USA, INC.
    Date Cleared
    2001-10-22

    (24 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Abbreviated
    Panel
    Dental
    Reference & Predicate Devices
    K974231
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    StatusBlue is indicated for use as a dental impression material in the following applications:

    • Situation impressions of any kind;
    • Impressions for the preparation of provisionals;
    • Impressions for orthodontic models;
    • Impressions of the opposing jaw;
    • Impressions for the manufacture of model cast dentures
    Device Description

    The StatusBlue dental impression material is a dimensionally stable polyvinyl siloxane material designed as an alternative to alginate impression materials. It will be supplied in prefilled, ready-to-use MixStar cartridges. StatusBlue is intended for use in commercially available impression trays.

    AI/ML Overview

    The provided text states: "Substantial equivalence for this device was based solely on design and technical specifications; no performance or safety data was included in this premarket notification." Therefore, the document does not contain information about acceptance criteria or a study proving the device meets them.

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