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510(k) Data Aggregation

    K Number
    K072273
    Device Name
    BELMONT QUOLIS 5000 SERIES DENTAL UNIT
    Manufacturer
    TAKARA BELMONT USA, INC.
    Date Cleared
    2007-12-20

    (127 days)

    Product Code
    NRD
    Regulation Number
    872.6640
    Why did this record match?
    Product Code :

    NRD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Unit and Accessories are intended for the Dentists, Hygienists, and Dental assistants for traditional and normal patient treatment procedures in the dental operatory.
    Device Description
    The Belmont QUOLIS 5000 SERIES DENTAL UNIT is a modification of the existing Belmont Dental Unit, Model 2000 series and Model 6000 series. It is a Dental Operative Unit and Accessories.
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    K Number
    K042266
    Device Name
    ACCLAIM
    Manufacturer
    AIR TECHNIQUES, INC.
    Date Cleared
    2004-08-31

    (8 days)

    Product Code
    NRD
    Regulation Number
    872.6640
    Why did this record match?
    Product Code :

    NRD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acclaim system is primarily a tool to provide visual information to dental patients so that they can better understand the necessity and quality of the health care they receive.
    Device Description
    Not Found
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