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510(k) Data Aggregation

    K Number
    K011211
    Manufacturer
    Date Cleared
    2001-06-18

    (60 days)

    Product Code
    Regulation Number
    872.3690
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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