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510(k) Data Aggregation

    K Number
    K962370
    Device Name
    PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE
    Manufacturer
    CHALLENGE PRODUCTS, INC.
    Date Cleared
    1997-03-31

    (285 days)

    Product Code
    EJR
    Regulation Number
    872.6030
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHALLENGE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the prophy paste is to help remove materia alba, plaque and resistant stains from the teeth.
    Device Description
    The device is a prophy paste which is used by dental professionals to help remove resistant stains from the surface of the teeth.
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