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510(k) Data Aggregation

    K Number
    K231635
    Device Name
    A-Line Advanced
    Manufacturer
    Biocetec Co., Ltd
    Date Cleared
    2023-06-06

    (1 days)

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

    Biocetec Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A-Line Advanced 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
    This orthodontic bracket is made of polycrystalline ceramic and is used for the treatment of malocclusion. It is designed to be attached to the surface of patients' teeth and be connected to the orthodontic wire in order to apply physical pressure on the tooth movement. Each model differs in size and dimension, color identification as they are attached to the tooth surface corresponding to 20 of the 28 permanent teeth.
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    K Number
    K163467
    Device Name
    C-Line Orthodontic Ceramic Bracket
    Manufacturer
    BIOCETEC CO., LTD
    Date Cleared
    2017-06-14

    (184 days)

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

    BIOCETEC CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    C-LineTM 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
    C-Line ™ orthodontic ceramic brackets are intended to be bonded to a tooth to apply pressure to a tooth to alter its position. C-Line ™ orthodontic ceramic brackets consist of a translucent alumina body and a bonding base. The bracket's color marking and cords indicates the bracket positioning and facilitate bracket identification.
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