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510(k) Data Aggregation

    K Number
    K092851
    Device Name
    MODEL GDCH-2000
    Date Cleared
    2009-09-29

    (13 days)

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

    GLOBAL DENTAL DIRECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Global GDCH - 2000 is a dental operative unit attached to patient chair. The dental operative unit is an AC-powered device that is intended to supply power to and serve as a base for other dental devices and accessories. The device also functions to deliver air, water and vacuum to the dental devices/accessories. The device is attached to dental patient chair, which is intended to properly position a patient to perform different dental procedures. The device is to be operated and used by dentists and other legally qualified professionals.
    Device Description
    The Global GDCH - 2000 is a dental operative unit attached to a dental patient chair. The design is very flexible with many functions, both left-handed and right-handed use is easily obtainable. The dentist and assistant are allowed to change their working postures and positions according to the operation to be performed. The versatile swiveling function enables fluent two-handed and four-handed treatment sequences. The unit is equipped with a digital control system with graphical user interface (GUI) to offer ease-of-use.
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