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510(k) Data Aggregation

    K Number
    K964942
    Device Name
    INFECTION CONTROL CARTRIDGE
    Manufacturer
    Date Cleared
    1997-06-19

    (191 days)

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

    DENTALPURE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    FOR USE TO REDUCE BACTERIA AND VIRUSES PRESENT IN DENTAL UNIT WATER LINE WATER. THE DEVICE CAN BE USED ON THE GENERAL PATIENT POPULATION, WITH THE EXCEPTION OF PATIENTS WHO ARE PREGNANT OF WHO ARE SENSITIVE TO IODINE.
    Device Description
    DENTAL UNIT WATER TREATMENT CARTRIDGE
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