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510(k) Data Aggregation

    K Number
    K083569
    Device Name
    SURGYBONE
    Manufacturer
    SILFRADENT S.R.L.
    Date Cleared
    2009-04-01

    (119 days)

    Product Code
    DZI
    Regulation Number
    872.4120
    Type
    Abbreviated
    Panel
    Dental
    Reference & Predicate Devices
    K080220,K060274,K043408
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    This is a 510(k) premarket notification for a medical device (K083560, SURGYBONE). This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies with defined acceptance criteria and performance metrics against a ground truth.

    Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets them. The document focuses on demonstrating that the SURGYBONE is substantially equivalent to already legally marketed predicate devices, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.

    Specifically, the document states:

    • "The proposed and predicated devices use similar components and are similar in design, technical characteristics and mode of operation. The proposed and the predicated devices are substantially equivalent."

    Without a clinical study comparing the SURGYBONE to a predefined set of acceptance criteria, there is no information available for the tables and points requested.

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