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510(k) Data Aggregation

    K Number
    K211010
    Device Name
    Illusion Aligners
    Date Cleared
    2021-04-26

    (21 days)

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

    Laxmi Dental Exports Pvt Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Illusion Aligners indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion.
    Device Description
    Illusion Aligners are intraoral thermoformed plastic aligners that are worn at least 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 are fabricated using a ten-step process. The Step 1 is to obtain the dimensions and details of the patient's baseline dentition. This is generally done using an oral scan data or a physical impression. Step 3, the scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning. In the Step 3, Laxmi Dental Exports Pvt Ltd, Inc. 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. Step 4, the treatment plan is sent to the doctor for approval. Upon approval, a 3D printer is used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed. Step 5 is the printing of 3D models of the treatment plan for use in Step 7 thermoforming. The thermoforming process is accomplished using a standard thermoforming equipment and the appropriate material as outlined in this submission.
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