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510(k) Data Aggregation

    K Number
    K150076
    Device Name
    Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L
    Date Cleared
    2015-06-02

    (139 days)

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

    DONG IL TECHNOLOGY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L are piezoelectric devices for surgery that enable mechanical ultrasound treatment, osteotomy and osteoplasty techniques to be applied in dental use.
    Device Description
    Sonic Surgeon 310L. Sonic Surgeon 600L and Sonic Surgeon 800L are ultrasonic surgical units intended for mechanical ultrasound treatment in prophylaxis, periodontics. The normal mode is tooth scaling applications, and the Boost Mode of Sonic Surgeon 310L. Sonic Surgeon 600L and Sonic Surgeon 800L can be used for surgical procedures, including osteotomy, osteoplasty, periodontal surgery and implantation. The tips can easily be changed during the treatment and must also be cleaned and autoclaved.
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    K Number
    K110881
    Device Name
    ULTRASONIC SURGICAL UNIT
    Date Cleared
    2011-12-16

    (261 days)

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

    DONG IL TECHNOLOGY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Ultrasonic Surgical Unit is a piczoelectric device for bone surgery that enables ostcotomy and ostcoplasty techniques to be applied to in dental use.
    Device Description
    Sonic Surgeon 300 is an ultrasound generator for use in dental surgery. And this device is used for surgical procedures, including osteonal surgery and in device your and implantation. Boost Mode can be used for mechanical ultrasound treatment in prophylaxis, periodontics or endodontics. The tips can easily be changed during the treatment and can also be cleaned and autoclaved. The Ultrasonic Surgical Unit transforms generated ultrasonic (26±3kHz) energy to the kinetic energy and transmits it to the tip. The generator of the Ultrasonic Surgical Unit performs automatic tuning of the operating frequency, the efficiency of the piezoelectric transducer in the handpiece.
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