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    K Number
    K191837
    Device Name
    UniSmile Clear Aligner System
    Manufacturer
    Vitang Technology, LLC
    Date Cleared
    2020-01-29

    (204 days)

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

    Vitang Technology, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UniSmile Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition. The UniSmile Clear Aligner System positions teeth by way of continuous gentle force.
    Device Description
    The UniSmile Clear Aligner System is fabricated of clear thin thermoformed plastics in a sequential series to progressively reposition the teeth. Corrective force to reposition the teeth is delivered via minor changes into a position in each subsequent aligner.
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