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510(k) Data Aggregation

    K Number
    K153048
    Device Name
    AcceleDent Aura
    Date Cleared
    2016-07-08

    (263 days)

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

    ORTHOACCEL TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AcceleDent® Aura is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.
    Device Description
    The AcceleDent® Aura is an orthodontic accessory for the treatment of tooth malocclusion. AcceleDent® Aura should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment.
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    K Number
    K130643
    Device Name
    ACCELEDENT AURA
    Date Cleared
    2013-04-23

    (43 days)

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

    ORTHOACCEL TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AcceleDent® Aura is intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement.
    Device Description
    AcceleDent® Aura is an orthodontic accessory for the treatment of tooth malocclusion. It is used as an adjunctive therapy for patients with orthodontic appliances such as braces to help facilitate tooth movement. AcceleDent® Aura should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment. AcceleDent® Aura includes the Activator, Mouthpiece and Travel Case. The Activator and connected Mouthpiece are used by patients to provide a light vibration to the teeth – the Activator vibrates at a 0.25 N (25 grams) force level and 30 Hz frequency for 20 minutes when turned-on; the vibration is transmitted from the Activator through the Mouthpiece to the patient's teeth as they lightly bite down on the Mouthpiece. The Activator and Mouthpiece assembly is light, comfortable, hands-free, and can be used while multi-tasking or while engaged in a variety of other daily activities. The Travel Case is an enclosure that may be used to conceal, protect, and keep the AcceleDent® Aura Activator and Mouthpiece clean while not in use. The device includes a USB port, which can connect directly into a computer or power supply to recharge the battery. The USB port can also be connected to a computer to display usage data. A USB Cable and Power Adaptor are included to complete the system.
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    K Number
    K110661
    Device Name
    ACCELEDENT
    Date Cleared
    2011-11-17

    (254 days)

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

    ORTHOACCEL TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AcceleDent is an orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement.
    Device Description
    The AcceleDent™ System is an orthodontic accessory for the treatment of tooth malocclusion. AcceleDent™ should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment with fixed appliances such as braces. The Activator and Mouthpiece assembly is light (2.7 oz or 75 g), comfortable, handsfree, and can be used while multi-tasking or while engaged in a variety of other daily activities.
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