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Found 4 results

510(k) Data Aggregation

    K Number
    K112508
    Device Name
    I-ROOT 100
    Manufacturer
    S-DENTI CO., LTD.
    Date Cleared
    2012-06-19

    (294 days)

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

    S-DENTI CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The i-ROOT 100 is intended for measuring the length of the root canal for the purpose of performing root canals and related dental procedures
    Device Description
    i-ROOT 100 is Electronic Apex Locator and accessories to be used to treat of patients. It consists of the main unit and lip clip, Cable assembly and 2 kinds of File holder.
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    K Number
    K112153
    Device Name
    IROOT 100 MINI
    Manufacturer
    S-DENTI CO., LTD.
    Date Cleared
    2012-04-26

    (294 days)

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

    S-DENTI CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The i-ROOT 100 mini is intended for measuring the length of the root canal for the purpose of performing root canals and related dental procedures.
    Device Description
    i-ROOT 100 mini is Electronic Apex Locator and accessories to be used to treat of patients. It consists of the main unit and lip clip, Cable assembly and 2 kinds of File holder.
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    K Number
    K100450
    Device Name
    I-ROOT
    Manufacturer
    S-DENTI CO., LTD.
    Date Cleared
    2010-11-18

    (274 days)

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

    S-DENTI CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The i-ROOT is intended for measuring the length of the root canal for the purpose of performing root canals and related dental procedures
    Device Description
    The subject device is a lightweight, fully-automatic, battery operated device that allows a dentist or oral surgeon to locate a patient's anatomical root canal apex and obtain accurate root canal length measurements
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    K Number
    K083901
    Device Name
    NAVI ROOT
    Manufacturer
    S-DENTI CO., LTD.
    Date Cleared
    2009-04-15

    (107 days)

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

    S-DENTI CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NAVI ROOT is intended for measuring the length of the root canal for the purpose of performing root canals.
    Device Description
    Not Found
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