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510(k) Data Aggregation

    K Number
    K991946
    Device Name
    ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L
    Manufacturer
    STERILEX CORP.
    Date Cleared
    1999-09-03

    (86 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    STERILEX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This product has been specially formulated and clinically proven to clean deposits and control bacterial contamination in Dental Unit Water Lines.
    Device Description
    Ultra-Kleen Powder for Dental Unit Water Lines, Models 513
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