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510(k) Data Aggregation

    K Number
    K982105
    Device Name
    ORAL POTENTIAL METER (OPM)
    Manufacturer
    PERTEC OF WISCONSIN, INC.
    Date Cleared
    1998-09-16

    (92 days)

    Product Code
    LFC
    Regulation Number
    872.1740
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERTEC OF WISCONSIN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Caries detection Device The Oral Potential Meter aids the dental professional in detecting potential caries. Meaurements above 10 millivolts, 1 microamp and 0.01 microwatts x seconds indicates a need for the dental professional to look at potentially carious leasions by also using other means, such as direct exploration, radiographs, etc. The OPM aids in determing potentially active caries and can not detect mineralized caries that have no potenial energy. Remineralized teeth are no longer considered carious.
    Device Description
    The OPM is a device that measures and displays voltage and conducts through caries related to metallic restorations in the oral cavity. The dentist may be able to, on visual exam, detect caries at the margins or with x-ray under a restoration with these readings. It also provides a power measurement (energy or joules) integrated over a measured period of time and displays it. The meter has two probes that are used to make the measurements. One is a reference probe, Red, with push-button switch to turn on the meter and initiate the measurements. The other is used as the primary input, Black to the meter's electronics
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