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510(k) Data Aggregation

    K Number
    K180718
    Device Name
    ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
    Manufacturer
    TOMY, Inc.
    Date Cleared
    2018-10-30

    (225 days)

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

    TOMY, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES are indicated for orthodontic movement of natural teeth.
    Device Description
    The ORTHODONTIC PLASTIC BRACKETS are designed to move teeth to improve their alignment. The ORTHODONTIC PLASTIC BRACKETS are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred positions can be used with bracket caps. The ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES consist of plastic orthodontic brackets, bracket caps, and buttons. The bracket caps are designed as an accessory of the orthodontic brackets for holding the archwire in the bracket's slot. Bracket caps are placed on the labial/buccal side of the brackets. The plastic buttons are designed to move teeth to improve their alignment. The plastic buttons are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position. The button design includes a round slot for attaching wires or other appliances.
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    K Number
    K123092
    Device Name
    CERAMIN BRACKETS Z
    Manufacturer
    TOMY, INC.
    Date Cleared
    2012-12-21

    (80 days)

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

    TOMY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CERAMIC BRACKETS Z are indicated for orthodontic movement on natural teeth surfaces.
    Device Description
    The CERAMIC BRACKETS Z are designed to move teeth to improve their alignment. The CERAMIC BRACKETS Z are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position. No accessories are marketed with the CERAMIC BRACKETS Z . The dental clinician is free to choose the bonding cement, supplemental ligatures and orthodontic wires for use with the brackets. The CERAMIC BRACKETS Z are composed of a polycrystalline zirconia ceramic bracket, which includes an archwire slot and tiewings. The self-ligating CERAMIC BRACKETS Z have a metal clip so that no other ligation of the archwire is needed.
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    K Number
    K123094
    Device Name
    ORTHODONTIC CERAMIC BRACKETS
    Manufacturer
    TOMY, INC.
    Date Cleared
    2012-12-13

    (72 days)

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

    TOMY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orthodontic Ceramic Brackets are indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
    Device Description
    The ORTHODONTIC CERAMIC BRACKETS are designed to move teeth to improve their alignment. The ORTHODONTIC CERAMIC BRACKETS are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position. No accessories are marketed with the ORTHODONTIC CERAMIC BRACKETS. The dental clinician is free to choose the bonding cement, supplemental ligatures and orthodontic wires for use with the brackets.
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