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510(k) Data Aggregation

    K Number
    K972642
    Device Name
    PERIO CONTROL II
    Manufacturer
    Date Cleared
    1998-01-26

    (195 days)

    Product Code
    Regulation Number
    872.4565
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESTRAD B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the "Perio Control II™" device is to screen patients and to track disease progression in the target population of patients who are suspected of having or already have periodontal disease. Both pediatric and adult patients may be tested.
    Device Description
    The Perio Control II™ is used during periodontal examination to measure gingival pocket depth. The pocket depth is displayed on the electronics unit and can be entered in an external computer system, either a PC or a Psion Series 3C) Also, the eventual occurrence of bleeding on probing can be registered, as well as the presence of supra-gingival plaque. This is judged visually and registered by pressing one of the buttons on the Perio Control IITM handpiece. The pocket depth is measured by entering the probe tip into the gingival pocket and forcing the filament of the probe up into the sleeve until the sleeve is at a specific reference point. In this position one of the buttons on the Perio Control II handpiece is pressed. The pocket depth is now displayed on the electronics unit.
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