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510(k) Data Aggregation

    K Number
    K190871
    Device Name
    Bio-TackS Orthodontic Mini Implant
    Manufacturer
    Bio Cetec Co., Ltd.
    Date Cleared
    2020-01-17

    (289 days)

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

    Bio Cetec Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bio-TackS Orthodontic Mini Implant is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
    Device Description
    Fixed on jawbone the Bio-TackS Orthodontic Mini Implant is a screw-shaped product used as a fixed point for orthodontic treatment and it is applied in order to secure sufficient physical and mechanical fixing source for treatment.
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    K Number
    K182193
    Device Name
    S-Line
    Manufacturer
    BIO CETEC CO., LTD.
    Date Cleared
    2019-01-22

    (161 days)

    Product Code
    NJM
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO CETEC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    S-Line™ orthodontic ceramic bracket is intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position
    Device Description
    S-Line™ orthodontic ceramic bracket is used to treat malocclusion, the abnormal occlusion of the upper and the lower teeth. It is intended to be applied on the surface of teeth to restore dental esthetics and functionality and it is designed to be used jointly with orthodontic wire.
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