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510(k) Data Aggregation

    K Number
    K033120
    Device Name
    SCALETRON PIEZO ULTRASOUND SCALER
    Manufacturer
    PAC-DENT INTERNATIONAL (SUZHOU), LTD.
    Date Cleared
    2004-01-29

    (121 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    PAC-DENT INTERNATIONAL (SUZHOU), LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scaletron™ is a Piezo Ultrasonic Scaler intended for use in fast and reliable removal of light to heavy calculus deposits and stains from teeth.
    Device Description
    The Scaletron ™ consists of the main scaler unit (including a peristaltic water pump), a hose, a connector for handpiece and a foot control switch. It is designed to generate regular linear tip movement at nominal 30 KHz.
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    K Number
    K030603
    Device Name
    PROANGLE DISPOSABLE PROPHY ANGLE
    Manufacturer
    PAC-DENT INTERNATIONAL (SUZHOU), LTD.
    Date Cleared
    2003-04-14

    (48 days)

    Product Code
    EGS
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    PAC-DENT INTERNATIONAL (SUZHOU), LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ProAngle™ disposable prophy angle is a device intended to polish and clean the surface of teeth. It should be attached to a low speed handpiece for operation.
    Device Description
    ProAngle™ disposable prophy angle is a device used for polishing and cleaning the surface of teeth. It consists of a pair of gears, a turning spindle and a drive spindle which can connect the low speed handpiece. The turning spindle has a prophylaxis cup on it for polishing or cleaning teeth.
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