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510(k) Data Aggregation

    K Number
    K230237
    Device Name
    Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)
    Manufacturer
    Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.
    Date Cleared
    2023-09-14

    (227 days)

    Product Code
    MQCKMY
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dental Braces are indicated for the fabrication of orthodontic and dental appliances, such as Orthodontic Appliances, Orthodontic Retainers, Mouth Guards and Splints.
    Device Description
    Not Found
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