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510(k) Data Aggregation

    K Number
    K130410
    Device Name
    DENTAL UNIT WITH CHAIR
    Manufacturer
    XIANYANG NORTH WEST MEDICAL INSTRUMENT (GROUP) CO.
    Date Cleared
    2013-07-26

    (157 days)

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

    XIANYANG NORTH WEST MEDICAL INSTRUMENT (GROUP) CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dental Unit with Chair is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
    Device Description
    The proposed device Dental Unit with Chair S2310 is a well equipped with two hands operation dental unit, which is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair. The proposed device is modification device to Dental Unit with Chair S2318 (K080438). It and the existed device share the same intended use, similar configuration, safety and performance. The proposed device consists of connection box, assistant holder, foot control, telescopic tray arm, instrument tray and operating light.
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