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510(k) Data Aggregation

    K Number
    K200908
    Device Name
    iSMILE
    Manufacturer
    Date Cleared
    2020-12-22

    (260 days)

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

    3D Diagnostix Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    iSMILE is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
    Device Description
    The iSMILE is a sequence of transparent aligners created from a digital orthodontic treatment plan. The iSMILE aligner is fabricated of a transparent thermoformed polyurethane plastic. Each aligner delivery a unique combination of minor forces to create the planned tooth movement. The digital orthodontic treatment plan is created by a dental health professional. The iSMILE Aligner incorporates the use of attachments to create spaces and force points in order to cause minor tooth movement. These force points are located in specific areas and positioned in such a way that they provide a continuous force which slowly dissipates over time on the tooth to be moved for as long as the aligner is worn.
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    K Number
    K202465
    Device Name
    Night Guard
    Manufacturer
    Date Cleared
    2020-11-25

    (90 days)

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

    3D Diagnostix Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Night Guard is indicated for protection against bruxism or nighttime teeth grinding. It creates a barrier between upper and lower dentition to protect the patient's overall occlusion.
    Device Description
    Night Guards are designated to alleviate the pain and damage caused by bruxing or clenching the teeth. Severe tooth, jaw or facial muscle pains are common side effects of bruxing or clenching the teeth. These patients specific devices fit over upper or lower teeth during sleep and can offset the effects of bruxing or clenching, while protecting teeth from daily wear and tear. Night Guard is shipped non-sterile.
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