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510(k) Data Aggregation

    K Number
    K150020
    Device Name
    Irritrol, EDS Combo-Rinse
    Manufacturer
    ESSENTIAL DENTAL SYSTESM, INC.
    Date Cleared
    2015-02-25

    (50 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESSENTIAL DENTAL SYSTESM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Irritrol™ is intended to cleanse and disinfect root canal systems after endodontic instrumentation.
    Device Description
    Irritrol™ is an aqueous solution for use during the irrigation phase of endodontic root canal preparation procedures. This multi-purpose device disinfects the root canal, flushes out any loosened debris, and removes the smear layer produced from root canal instrumentation.
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