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510(k) Data Aggregation

    K Number
    K190948
    Device Name
    Magic Clear Aligners
    Date Cleared
    2019-05-09

    (28 days)

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

    Voodoo Manufacturing, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Magic Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.
    Device Description
    Magic Clear Aligners consist of a series of custom-made removable plastic orthodontic appliances which sequentially reposition teeth by way of continuous gentle force. A digital or traditional mold impression of the patient's teeth is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data created of the patient's teeth, specialized orthodontic CAD/CAM software is used to develop treatment plans. Using the software, dental technicians design a series of intermediate models corresponding to each stage of treatment, gradually realigning the patient's teeth according to the dental health professional's prescription. The prescribing doctor reviews and approves the model scheme and treatment plan before the molds/models are produced. Once approved, the specialized orthodontic software is used to generate standard format 3D files which are used to physically produce each model/mold in the treatment plan for aligner fabrication. Voodoo Manufacturing produces the aligner trays by thermal forming a plastic sheet over each model in the treatment plan. The aligner trays are sent to the dental health professional who then delivers them to the patient, confirming fit and design. Over a period of time, additional trays are provided sequentially to the patient by the dental health professional to gradually move the teeth to the desired position. The dental health professional monitors treatment from the first aligner is delivered to when the final aligner is delivered and treatment complete. The aligners are held in place by pressure and can be removed by the patient at any time.
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