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510(k) Data Aggregation

    K Number
    K070289
    Device Name
    ACQUASEAL BENZ
    Date Cleared
    2007-05-04

    (94 days)

    Product Code
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACQUAMED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Acquaseal Benz is indicated for dental restorative, hypersensitivity, cervical, and hygiene procedures.
    Device Description
    Hydrophilic liquid containing Hydroxyethyl- methacrylate (HEMA), Fluoride and Benzakonium Fluoride.
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