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510(k) Data Aggregation

    K Number
    K091913
    Device Name
    HI TECH IMPLANT, HT PHYSIO IMPLANT
    Manufacturer
    Date Cleared
    2009-10-30

    (122 days)

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

    BY DENTAL SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Hi-Tech Implant/HT Physio Implant are intended to prepare Intraoral bone for implantology procedures.
    Device Description
    The HI TECH IMPLANT and HT PHYSIO IMPLANT consist of a microprocessor controlled unit, foot pedal, electric micromotor, support rods and sterile, disposable irrigation tubes. The unit also houses the peristaltic pump. The HI TECH IMPLANT and HT PHYSIO IMPLANT provide electronic control of velocity and torque. The HI TECH IMPLANT and HT PHYSIO IMPLANT can be programmed and retain programs into memory. The HI TECH IMPLANT and HT PHYSIO IMPLANT are fully operational from foot pedal.
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