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510(k) Data Aggregation

    K Number
    K211026
    Device Name
    Minitube Dentasleeve Protective Barrier Sleeves
    Manufacturer
    Minitube AB
    Date Cleared
    2021-08-03

    (119 days)

    Product Code
    PEM
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    Minitube AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Minitube Dentasleeve Protective Barrier Sleeves are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only
    Device Description
    Minitube Dentasleeve Protective Barrier Sleeves are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These disposable barrier sleeves are offered in various shapes and sizes to fit over and cover the intended dental instruments and equipment. The disposable Barrier Sleeves slip over the ends of the respective devices, allowing for the attachment of those parts of the devices used during dental procedures. Barrier Sleeves act as a physical barrier, augmenting existing infection control techniques, and facilitate clean up. The Minitube Dentasleeve Protective Barrier Sleeves are available in below sizes. All sizes below are provided in millimeters (mm, approx.) and excluding paper liner, i.e. actual sleeve only: - . 1 ml Width: 29 mm Length: 148 mm - 5 ml Width: 43 mm Length: 195 mm - 50ml Width: 63 mm Length: 126 mm
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