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510(k) Data Aggregation

    K Number
    K221814
    Device Name
    OK Handpiece
    Manufacturer
    Date Cleared
    2022-07-15

    (23 days)

    Product Code
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jaintek Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A dental contra-angle handpiece that attaching a vertical reciprocating dental strips intended to be used in interproximal reduction of teeth; And it is part of orthodontic treatment of finishing interdental and subgingival area, finishing cavity edges, removing the dentin of teeth adjacent, removing subgingival plague and tripping. The device incorporates a small micro motor normally driven by compressed air; This is a reusable device.
    Device Description
    The OK handpiece is a reciprocating contra-angle handpiece that is used in connection with an air motor. The rotational force of the air motor is transmitted to the handpiece head through the shaft of the handpiece body, and the rotational force of the shaft is converted into vertical reciprocating motion in the head. The OK handpiece is a reprocessing medical device. Users must steam sterilize before each use, and clean thoroughly after use. The OK handpiece does not have water/air spray and light supply. Therefore, the air motor connection of the handpiece is designed to comply with the coupling size of TYPE 1 of ISO 3964. For the strip connecting to the OK handpiece, you must use Orthok-Strips and OK Proxofile of Jaintek Co., Ltd.
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