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510(k) Data Aggregation

    K Number
    K210422
    Device Name
    INTAI Surgical Mask (non-sterile)
    Date Cleared
    2022-03-30

    (412 days)

    Product Code
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTAI Technology Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    INTAI Surgical Mask is intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials. This is a single use, disposable device and provided non-sterile.
    Device Description
    The INTAI Surgical Mask is single use, three-layers, flat-pleated masks with ear loops, and nose clip. The inner and outer layers are made of Non-woven fabric (Polypropylene), and the middle filter layer is made of a melt blown fabric (Polypropylene). The ear loops welded are used to keep the mask close to the mouth and the nose. The ear loops are made of Nylon. The nose clip, which is made by plasticity material (HDPE), contained in masks is in the layers of the surgical mask to allow the users to fit the facemask around their nose. The surgical mask are provided in one color (blue), non-sterile and intended to be single use, disposable device.
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    K Number
    K122804
    Device Name
    ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM
    Date Cleared
    2013-05-20

    (249 days)

    Product Code
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTAI TECHNOLOGY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Royal-Dent Eureka Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cemented retained, screw retained or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Royal-Dent Eureka Dental Implant System is for one and two stage surgical procedures. It's not for immediate load.
    Device Description
    Royal-Dent Eureka Dental Implant System is a multiple component device, made from CP Ti and Ti-6Al-4V, which allow the surgeon to build an implant system to fit the patient's requirements. The system is a set of implants designed to be inserted into the upper and/or lower jawbone and serves as a replacement for patient's tooth providing a stable foundation for restorations. The system is provided with simplified main implants, but with a variety of different styles of components. Eureka and Eureka Plus implant series are the sub-types incorporated into Royal-Dent Dental Implant System. The major difference between two implant sub-types is outer design configuration. The design configuration and features of inner hole for the sake of fitness to various screws and abutments are identical. The Implants are provided sterile, the remaining components must be sterilized prior to use.
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