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510(k) Data Aggregation

    K Number
    K220726
    Device Name
    K Clear
    Manufacturer
    Date Cleared
    2022-03-16

    (2 days)

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

    K Line Europe GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    K Clear aligners are indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars).
    Device Description
    The K Line K Clear aligners are a series of prescription-only clear plastic removable aligners intended to incrementally move a patient's teeth from an initial position to a different end position using a softwaregenerated sequence of intermediate states. K Clear sequentially reposition teeth by way of continuous gentle force.
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