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510(k) Data Aggregation

    K Number
    K132315
    Device Name
    ERGONOMIC PRODUCTS WORKSTATION
    Date Cleared
    2014-04-18

    (267 days)

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

    ERGONOMIC PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ergonomic Products Workstation is a dental operative unit, which 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 is to be operated and used by dentists and other legally qualified professionals.
    Device Description
    The Ergonomic Products Workstations provide a consolidated work area for the purpose of delivering air, water, vacuum, and electricity to handheld instruments, and is for use in a professional dental office by professional dental practitioners for administering care to dental patients. Ergonomic Products manufactures dental office delivery units in several formats, all using the same technology - Doctor Workstation, Hygiene Inwall Workstation, Universal Cart and Assistant Cart.
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