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510(k) Data Aggregation

    K Number
    K233918
    Device Name
    Dental Barrier and Sleeves
    Manufacturer
    Yongqing Huaguan Dental Instruments Factory
    Date Cleared
    2024-05-09

    (148 days)

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

    Yongqing Huaguan Dental Instruments Factory

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Barrier and Sleeves are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
    Device Description
    Dental Barrier and Sleeves consist of various sizes and shapes of polyethylene covers which are positioned on various small hand-held dental instruments such as hand pieces, curing lights, air/water syringes and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument trays, x-ray heads, and others. The products are sold non-sterile, prepackaged, and are disposable, single use only.
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