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510(k) Data Aggregation

    K Number
    K083569
    Device Name
    SURGYBONE
    Manufacturer
    Date Cleared
    2009-04-01

    (119 days)

    Product Code
    Regulation Number
    872.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    SILFRADENT S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is a dental bone cutting instrument performing operations in the field of oral surgery.
    Device Description
    SURGYBONE, the electromedical equipment by SILFRADENT Srl, is a dental instrument performing operations in the field of dental prosthesis and endodontics by means of ultrasound vibrations produced by a piezoelectric transducer. The equipment consists of a console including an electronic control circuit and an ultrasound control circuit, a piezoelectric handpiece and a peristaltic pump. Suitable tips are mounted to the piczoelectric handpiece. The system is based on a sophisticated ultrasvund control structure, which by means of current measurement, carries out electrical resonance handpiece control. All operations are displayed and controlled by a card through a monitor and a keyboard. The integrated pump is used to transport the sterile coolant from its vessel to the preparation point.
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