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510(k) Data Aggregation

    K Number
    K033597
    Device Name
    ATR 5000, LC 5000, IMPLANT SYSTEM
    Manufacturer
    ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L.
    Date Cleared
    2003-11-25

    (11 days)

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

    ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These ATR Surgical Micromotors are intended to prepare Intraoral bone for implantology procedures.
    Device Description
    The ATR Surgical Micromotors ATR5000, LC5000 and Implant System, are microprocessor driven surgical micromotors used in implantology procedures. The ATR Surgical Micromotors ATR5000, LC5000 and Implant System consists of a microprocessor controlled unit, foot pedal, electric micromotor, support rods and sterile, disposable irrigation tubes. The units also house the peristaltic pump. The ATR Surgical Micromotors ATR5000, LC5000 and Implant System provide electronic control of velocity and torque. The ATR Surgical Micromotors ATR5000, LC5000 and Implant System can be programmed and retain programs in memory. The ATR Surgical Micromotors ATR5000, LC5000 and Implant System are fully operational from foot pedal.
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