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510(k) Data Aggregation

    K Number
    K171577
    Device Name
    Smartcord, Smartcord X
    Manufacturer
    EASTDENT Co., Ltd
    Date Cleared
    2018-05-03

    (338 days)

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

    EASTDENT Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Smartcord is knitted retraction cord made from 100% cotton for the temporary gingival retraction. Smartcord X is knitted retraction cord made from 100% cotton, impregnated with Aluminum Chloride for the temporary gingival retraction and hemostasis of the gingival margin.
    Device Description
    Smartcord is non-impregnated knitted retraction cord made from 100% cotton. Smartcord X is knitted retraction cord made from 100% cotton, impregnated with Aluminum Chloride Hexahydrate.
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