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510(k) Data Aggregation

    K Number
    K130180
    Device Name
    CLEANSER ROOT CANAL
    Manufacturer
    CERKAMED WOJCIECH PAWLOWSKI
    Date Cleared
    2013-10-03

    (251 days)

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

    CERKAMED WOJCIECH PAWLOWSKI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Liquid used for root canal rinsing during endodontic treatment. During mechanical canal widening it removes the non-vital pulp debris. it cleans the canal and removes at the same time smear layer in order to expose dentinal tubuli orifices before canal filling.
    Device Description
    Liquid for root canals rinsing
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