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510(k) Data Aggregation

    K Number
    K150696
    Device Name
    Jade 37% Phosphoric Acid Etchant Gel
    Manufacturer
    Dharma Research, Inc.
    Date Cleared
    2015-06-23

    (97 days)

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

    Dharma Research, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A thixotropic 37% phosphoric acid dental etchant gel for etching enamel, dentin, and glass ionomer cements to produce the necessary micro-retentive surface for successful bonding of restorations.
    Device Description
    Thixotropic dental etchant gel with 37% phosphoric acid
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