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    K Number
    K213093
    Device Name
    STEP-1 PumEtch
    Manufacturer
    Rounding Third LLC
    Date Cleared
    2022-01-28

    (126 days)

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

    Rounding Third LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    STEP-I PumEtch is a prophylaxis and phosphoric acid etchant treatment intended for the smface preparation of dentin or enamel prior to tooth restoration, including the application of sealants or for bonding.
    Device Description
    STEP-1 PumEtch is a tooth preparation formulation combining a 37% phosphoric acid etch and pumice, a polishing agent, into one gel liquid solution. The product is used to prepare natural tooth surfaces for the application of sealants or direct bond appliances.
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