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510(k) Data Aggregation

    K Number
    K190608
    Device Name
    Mei Ceramic Bracket
    Manufacturer
    Date Cleared
    2019-11-04

    (238 days)

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

    Orthosun Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This Mei Ceramic Bracket is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only.
    Device Description
    The proposed device, Mei Ceramic Bracket, consists of ceramic orthodontic brackets which are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontics wire, to alter the tooth position. The ceramic bracket is produced using Al203, translucent polycrystalline aluminum oxide (99.99%). The brackets are bonded to the teeth with commercially available materials and linked together by "arch wire" that applies steady, gentle pressure to produce desired tooth movement.
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