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510(k) Data Aggregation

    K Number
    K141104
    Device Name
    TRUKLEAR BRACKET
    Manufacturer
    AJW TECHNOLOGY CONSULTANTS, INC.
    Date Cleared
    2014-06-25

    (57 days)

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

    AJW TECHNOLOGY CONSULTANTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended for single use only.
    Device Description
    The Orthodontic Ceramic Brackets are bonded to teeth to apply forces to the tooth, transmitted, to alter the tooth position. The force is introduced by a flexible orthodontic wire, which is attached to Orthodontic Ceramic Brackets. The ceramic bracket has both, aesthetic and self ligating qualities. The bracket design enables easier orthodontic wire placement and removal through self-ligating properties.
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    K Number
    K131893
    Device Name
    AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS
    Manufacturer
    AJW TECHNOLOGY CONSULTANTS, INC.
    Date Cleared
    2013-10-30

    (127 days)

    Product Code
    FSY
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    AJW TECHNOLOGY CONSULTANTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Amico iCE LED series surgical lights are to provide high intensity, shadow free illumination to the patient surgical field during surgical procedures. The intended use of the Amico Mira LED series minor surgery lights is to provide high intensity, shadow free illumination to the patient surgical field during minor surgery procedures.
    Device Description
    Amico iCE series consists of 3 models - iCE-30-6, iCE-25-6, & iCE-25-3. These are major surgical luminaires that provide illumination in a surgical suite allowing doctors to operate on a patient.. The device comes with several built-in fail safe's preventing any single fault from creating a hazardous situation. These lamps are a Class 2 device (under FDA) providing max illumination of 160,000 lx, 160.0001x, and 130.000 Ix respectively. These surgical lights are coupled with ceiling mounted suspension systems supporting horizontally articulating extensions arms and horizontally and vertically articulating spring arms. Both arms can rotate either 340 degree (with stop) or infinitely without a stop. The spring arms vertically articulate 50° downwards and 45° upwards. This allows for ease of movement of the lamp head to any given position. The lamp housing is made of high quality plastic wrapped around an aluminum structure. The front clear glass is made of high quality polycarbonate material. The yoke connecting the lamp head to the spring arms is made of steel. The lamps also have a built-in mechanical focusing system that is controlled using the center Aluminum and/or plastic handle. Rotating this handle allows the user to expand and contract the lighted field as per the user's requirement. The lamps can also be sold with an optional in-light camera that doubles as a focusing handle. This provides the user with the option to record/display small areas of a surgical site on a large display allowing for greater detail and accuracy during surgeries. A separate remote control is used to control the various functions of the camera. Amico Mira LED series consists of 3 models - Mira LED 90, Mira LED 65 & Mira LED 50. These are minor surgical luminaires that provide illumination in a surgical suite allowing doctors to perform minor surgical procedures on a patient. These lamps are a Class 2 device (under FDA) providing max illumination of 90.000 1x. 65.000 Ix, and 50.000 Ix respectively. These surgical lights are coupled with ceiling mounted suspension systems supporting horizontally articulating extensions arms and horizontally and vertically articulating spring arms. Both arms can rotate either 340 degree (with stop) or infinitely without a stop. The spring arms vertically articulate 50° downwards and 45° upwards. This allows for ease of movement of the lamp head to any given position. The lamp housing is made of high quality plastic which connects to the front clear glass is made of high quality polycarbonate material. The yoke connecting the lamp head to the spring arms is made of steel. The lamps also have a built-in electronic focusing system that is controlled using the center Aluminum/plastic handle. Rotating this handle allows the user to expand and contract the lighted field as per the user's requirement.
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