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510(k) Data Aggregation

    K Number
    K201604
    Device Name
    Plasdent Disposable Barrier Sleeves and Barrier Film
    Manufacturer
    Plasdent Corporation
    Date Cleared
    2020-12-23

    (191 days)

    Product Code
    PEM
    Regulation Number
    878.4370
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    Applicant Name (Manufacturer) :

    Plasdent Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Plasdent Disposable Barrier Sleeves and Barrier Film are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient one time use only.
    Device Description
    Plasdent Disposable Barrier Sleeves and Barrier Film are made of polyethylene film (PE), and come in various shapes and sizes as dental accessories intended to fit over and cover dental instruments and equipment. The Disposable Barrier Sleeves cover small hand-held dental instruments such as air/water syringes, curing lights, hand pieces, computers, sensors, dental instrument trays, and other similar handheld instruments to provide as a physical barrier or cover during a dental procedure. In other forms, the Disposable Barrier Film Covers are used to cover equipment, such as dental chairs, headrests, X-Ray heads, and other devices. The device is non-sterile, prepackaged, and is disposable, for single patient and one time use only.
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