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510(k) Data Aggregation

    K Number
    K131248
    Device Name
    ETCH GEL
    Manufacturer
    DMG AMERICA, LLC
    Date Cleared
    2013-07-11

    (71 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    DMG AMERICA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Preparation of tooth material prior to restoration by etching of the surface.
    Device Description
    The device described in this 510(k) consists of a water-based gel containing 40% phosphoric acid.
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