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510(k) Data Aggregation

    K Number
    K070127
    Device Name
    PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02
    Manufacturer
    KEVIN VU, DDS
    Date Cleared
    2007-03-29

    (72 days)

    Product Code
    EMN
    Regulation Number
    872.4565
    Why did this record match?
    Product Code :

    EMN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Plaque Scraper-A Interproximal (between teeth) Plaque Remover is an effective cleansing device which removes plaque and food between the teeth as part of a program for good oral hygiene to supplement the regular professional care required for oral health. This product is intended for personal oral hygiene use.
    Device Description
    The Plaque Remover is a plastic product designed with an elongated handle for ergonomic convenience and has dual rounded and beveled points on each end.
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