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510(k) Data Aggregation

    K Number
    K132356
    Device Name
    SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST
    Manufacturer
    SCICAN GMBH
    Date Cleared
    2014-01-31

    (186 days)

    Product Code
    EGS, CLA, SAN
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCICAN GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This medical device is only intended for dental treatment in the area of dentistry. Is is intended to be used for the following applications: - SANAO 200 L / 40 ST: The removal of decayed matter, cavity and crown preparations, the removal of filings and surface finishing of tooth and restoration surfaces. - SANAO 40 / 40 L. / 10 / 10 L.: Cavity preparations, caries excavation, endodontics, surface finishing of tooth and restoration surfaces. - SANAO PSI / PSO: prophylaxis treatment.
    Device Description
    All SANAO Contra-Angle and Straight dental handpieces can be powered by an air-motor or an electronic micro-motor and are intended for use by trained professionals in the field of general dentistry. They are ergonomically shaped, reusable and some models are optionally available with a glass rod lighting system. Depending on the model the devices possess a 1- or 3- port spray or no spray. For different applications and tools there is a range of devices available with different transmissions for maximum output rotations ranging from 8,000 to 200,000 rpm. The devices are color-coded according to their respective gear ratio. The shanks of the instruments are in conformance with the respective ISO standards.
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