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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
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K042905,K092030,K080906,K053055
    Why did this record match?
    Device Name :

    ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    This device, "ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES", is not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable here.

    The document describes an orthodontic product (brackets, bracket caps, and buttons) and its substantial equivalence to previously marketed predicate devices, focusing on material composition, mechanical properties, and intended use. The performance data section refers to standard material testing and conformity to ISO standards, not AI/ML algorithm performance.

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