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510(k) Data Aggregation

    K Number
    K190484
    Device Name
    BH Medical Dental Barrier Sleeves and Barrier Film
    Manufacturer
    BH Medical Products Co., Ltd.
    Date Cleared
    2019-09-10

    (195 days)

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

    BH Medical Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BH Medical Dental 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 use only.
    Device Description
    BH Medical Dental Barrier Sleeves and Barrier Film consist of various sizes and shapes of clear 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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    K Number
    K172280
    Device Name
    BH Sterilization Pouch
    Manufacturer
    BH Medical Products Co., Ltd.
    Date Cleared
    2018-08-03

    (371 days)

    Product Code
    FRG, JOJ, KCT
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    BH Medical Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BH sterilization pouch is intended to provide dentists with an effective method to enclose devices intended for sterilization in steam auto claves. The recommended pre-vacuum steam sterilization cycle parameters are 4 minutes at 132°C (270°F). The sterilization pouch maintains the enclosed devices up until 180 days post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the pouch has undergone a steam sterilization process. Only one instrument can be sterilized in one pouch and only instruments that are be metal, hinged, or knurled can be sterilized in the pouch.
    Device Description
    The pouches are made from a medical grade paper and plastic film that is heat sealed on three sides. The forth side has an adhesive strip that is used to seal the paper to the film prior to sterilization of the enclosed medical device. The medical grade paper conforms to recognized material standards and can be steam sterilized. The process indicator ink printed on the medical paper will exhibit a color change after the pouch is exposed to steam sterilization. The device is disposable, single use only.
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