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510(k) Data Aggregation

    K Number
    K973765
    Device Name
    BIO-2000
    Date Cleared
    1998-11-04

    (398 days)

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

    MICRYLIUM LABORATORIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For use in pressurized self-contained water devices. For use in cleaning lines in dental units by leaving the solution (Bio2000), dispensed by a pressurized device, overnight (similar period of time) or use continuously. Cleaning lines refers to the reduction of microbial contamination. For use in operative procedures to dedicated coolant (water) line for air or electric driven handpieces and scalers. Use of this device and solution will increase cutting efficiency and decrease the bad odors and tastes that occur during operative procedures while decreasing microbial contamination of the lubing.
    Device Description
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