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510(k) Data Aggregation

    K Number
    K221537
    Device Name
    Nightwear Aligners
    Manufacturer
    Date Cleared
    2023-04-05

    (313 days)

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

    Smylio Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Nightwear Aligners are indicated for the alignment of permanent teeth during orthodontic treatment of malocclusion.
    Device Description
    The Smylio Nightwear Aligners are thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn at least 9 to 12 hours a day and are to be removed for eating and for cleaning. Smylio Nightwear Aligners are designed from digital scans of a patient's dentition submitted by a dental health professional (e.g., dentist or orthodontist). Using the scan, sequential dental models are designed and approved by the treating physician prior to manufacturing. Once the treatment plan is reviewed and approved by a dental health professional, each 3D model from the treatment plan is manufactured. The aligner trays are then manufactured by thermoforming a dental thermoplastic sheet over each model. The aligners are shipped to the treating clinician's office where they are then distributed to the patient in sequential stages. The patients' dental health professional then monitors their treatment of the first aligner to the delivery of the final aligner. Nightwear Aligners are a sequence of transparent aligners created from a digital orthodontic treatment plan. The Nightwear Aligners are fabricated of a transparent thermoformed polyurethane plastic. Each aligner delivers 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 Nightwear Aligners incorporate 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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