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510(k) Data Aggregation

    K Number
    K222619
    Device Name
    Ensmile
    Manufacturer
    Date Cleared
    2023-03-16

    (198 days)

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

    Ensmile Pvt Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Ensmile Dental Plastic Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion.
    Device Description
    The Ensmile is a sequence of transparent aligners created from a digital orthodontic treatment plan. The Ensmile 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 Ensmile 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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