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510(k) Data Aggregation

    K Number
    K233356
    Device Name
    Illusion Aligner Pro: Illusion Aligner FLX
    Manufacturer
    Laxmi Dental Export PVT. LTD
    Date Cleared
    2024-08-08

    (314 days)

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

    Laxmi Dental Export PVT. LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Illusion Aligners Pro are indicated for use in the alignment teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion. Illusion Aligner Flx are indicated for use in the alignment teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion.
    Device Description
    A dental health professional (e.g., an orthodontist or a dentist) prescribes the Illusion Aligners Pro and Illusion Aligner Flx are based on an assessment of the patient's teeth. The dental health professional (dentist/orthodontist) takes either the intraoral scans or physical impressions of the patient's teeth, determines the required corrections to align the teeth, and 3Shape's Ortho System is used for treatment planning. Illusion Aligners Pro and Illusion Aligner Flx are intraoral thermoplastic appliances that are worn 20 to 22 hours per day and are designed to be used in a sequence, each aligner providing a gentle continuous force, to allow for the movement of teeth to the final desired position. The aligners are to be removed for eating and for cleaning. Illusion Aligners Pro and Illusion Aligner Flx are fabricated using a three- step process. The first step is to obtain the dimensions and details of the patient's dentition. This is generally done using an intraoral scan or a physical impression. This scanned data (digital CAD/CAM models or patient models) is imported into specialized dental software for treatment planning. The second step is the printing of 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, Illusion Aligners Pro and Illusion Aligner Flx utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the teeth into their final desired position. The treatment plan is sent to the doctor for approval. Upon approval, a 3D printer is used to create the models needed for each treatment step to provide the surface around which the aligner is thermoformed. The final step is the thermoforming of a plastic sheet material to each of the sequential treatment steps. This process is done using standard thermoforming equipment and the appropriate material as specified. The trays are provided to the dental health care professional who provides them to the patient in sequential stages, confirming fit and design. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is finished, and treatment is complete
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