Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K152167
    Device Name
    BIJOU Orthodontic Ceramic Bracket
    Date Cleared
    2016-05-27

    (297 days)

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

    WORLD BIO TECH CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BIJOU Orthodontic Ceramic bracket is indicated for orthodontic movement of natural teeth.
    Device Description
    Orthodontic Ceramic bracket, BIJOU is composed of single crystal alumina and consists of three parts: the first part is the slot for the orthodontic wire; the second part is a round groove that is to hold a wire with an elastic "O" ring; the third part is the base that adheres to the tooth surface. A colored marking on wing part of bracket indicates orientation for placement.
    Ask a Question

    Ask a specific question about this device

    K Number
    K120471
    Device Name
    MACH BRACKETS BRIGHT BRACKETS
    Date Cleared
    2012-06-04

    (109 days)

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

    WORLD BIO TECH CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended for orthodontic movement of teeth. It is used temporarily and is removed affer orthodontic treatment has been completed. The devices are intended to be single used only.
    Device Description
    The MACH BRACKETS are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The modified orthodontic ceramic bracket has both aesthetic and self-ligating qualities. The modifications were aimed at facilitating easier orthodontic wire placement and removal through self-ligation and enhancing the bonding and debonding characteristics of the bracket. The MACH BRACKETS is produced using Al2O3, translucent polycrystalline aluminum oxide (99.99%). This MACH BRACKETS are bonded to the teeth with commercially available materials and linked together by "arch wire" that applies steady, gentle produce desired tooth movement.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1