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510(k) Data Aggregation

    K Number
    K131510
    Device Name
    POLYDIMETHYLSILOXANE IMPRESSION MATERIAL
    Manufacturer
    BLACKWELL DEVICE CONSULTING
    Date Cleared
    2013-12-20

    (210 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    BLACKWELL DEVICE CONSULTING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Polydimethylsiloxane Impression Material is used as an impression material in a dual phase impression technique. It may also be used for precise duplication of models. Regular Set material is used for capturing multiple unit restorations. Fast Set is used for capturing one preparation only(single unit crown) and is ideal for double arch dual phase techniques.
    Device Description
    Polydimethylsiloxane Impression Material
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