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510(k) Data Aggregation

    K Number
    K083284
    Device Name
    PIEZOSURGERY MEDICAL
    Manufacturer
    PIEZOSURGERY SRL
    Date Cleared
    2009-04-08

    (152 days)

    Product Code
    JDX, DZI, ERL, HBE, HWE
    Regulation Number
    888.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    PIEZOSURGERY SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Piezosurgery MEDICAL is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone, osteotomy, osteoplasty and drilling in variety of surgical procedures, including but not limited to otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and plastic/reconstructive surgery. It may also be used with endoscopic visual assistance to perform the above listed procedures.
    Device Description
    The Piezosurgery® Medical device is an ultrasonic surgical system consisting of a central console with two integral peristaltic irrigation pumps, and two detachable handpieces. Each handpiece is connected to the console electrically, and each is also connected to one of the irrigation pumps via an irrigation tubing kit. The handpieces contain the ultrasonic transducers. A separate electricallyoperated footswitch is provided with the device, which also attaches to the central console. The irrigation tubing kits and insert tips are supplied sterile and are intended for single-use. A range of optionally available handpiece tips provides the surgeon with a wide variety of options for drilling, cutting and sawing. The console has a touch-screen display and contains general control system circuits and two ultrasonic generators which drive the handpiece functions. The irrigation tubing kit is fed with physiological saline solution during the surgical procedure from saline bags (not supplied) which hang from drip stands that attach to the rear of the central console. The user may activate either of the two handpieces by the selection from the LCD touch-screen and by pressing the footswitch.
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    K Number
    K052518
    Device Name
    PIEZOSURGERY
    Manufacturer
    PIEZOSURGERY SRL
    Date Cleared
    2005-11-16

    (63 days)

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

    PIEZOSURGERY SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Piezosurgery® device is intended for use in the following dental applications: - Bone cutting for use in oral surgery (K043408) - - Removing supra and subgingival calculus deposits and stains from teeth - - Periodontal pocket lavage with simultaneous ultrasonic tip movement - - Scaling and root planing - - Retrograde preparation of root canals
    Device Description
    The Piezosurgery® device uses piezoelectric ultrasonic technology to generate mechanical microvibrations for bone cutting and ultrasonic scaling, with minimal trauma to soft tissue. The device is supplied with sharp, smoothing and blunt insert tips for use in oral surgery, including implantology, periodontal surgery, endodontic surgery and surgical orthodontics.
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    K Number
    K043408
    Device Name
    PIEZOSURGERY DEVICE
    Manufacturer
    PIEZOSURGERY SRL
    Date Cleared
    2005-06-08

    (180 days)

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

    PIEZOSURGERY SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Piezosurgery device is a bone cutting instrument intended for use in oral surgery.
    Device Description
    The Piezosurgery® device uses piezoelectric ultrasonic technology to generate mechanical The riezdsurgery done cutting, with minimal trauma to soft tissue. The device is supplied mith sharp, smoothing and blunt insert tips for use in oral surgery, including implantology, periodontal surgery and surgical orthodontics.
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