Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K091227
    Device Name
    PIEZOSURGERY 3; OSSTEM PIEZO
    Manufacturer
    PIEZOSURGERY S.R.L.
    Date Cleared
    2009-12-29

    (245 days)

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

    PIEZOSURGERY S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSSTEMPiezo is intended for use in the following dental applications: - Bone cutting for use in oral surgery - 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 The Piezosurgery 3 is intended for use in the following dental applications: - Bone cutting for use in oral surgery - 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 OSSTEMPiezo 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 rer smoothing and blunt insert tips for use in oral surgery, including implantology, periodontal surgery, endodontic surgery and surgical orthodontics. The device uses piezoeledric ultrasonic technology to generate mechanical microvibrations of insert tips for cutting mineralized structures with minimal trauma to soft tissue and for ultrasonic scaling.
    Ask a Question

    Page 1 of 1