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510(k) Data Aggregation

    K Number
    K102223
    Device Name
    CHALLENGE-EVER
    Date Cleared
    2011-02-25

    (203 days)

    Product Code
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    HALLIM DENTECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CHALLENGE-EVER is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is intended for use in the dental clinic environment and used by trained dentists and/or dental technicians and assistants.
    Device Description
    Not Found
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