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510(k) Data Aggregation

    K Number
    K003422
    Device Name
    EDTA ROOT CANAL CLEANSER
    Manufacturer
    SUPER GLIDE, INC.
    Date Cleared
    2001-01-19

    (77 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUPER GLIDE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992919
    Device Name
    OXY-GLIDE ROOT CANAL CLEANSER & LUB.
    Manufacturer
    SUPER GLIDE, INC.
    Date Cleared
    1999-11-19

    (81 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUPER GLIDE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used in the chemical and mechanical cleansing of the root canal preparation during endodontic therapy
    Device Description
    Oxy Glide™ allows for cleansing action that facilitates easy removal of vital pulp tissue and necrotic pulp tissue from the root canal. It is designed to be used with endodontic irrigation with sodium hypochlorite solutions. Oxygen bubbling occurs through the release of oxygen from the urea peroxide. This action allows for the pulp tissue, dentinal shavings, and debris to float out.
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