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510(k) Data Aggregation

    K Number
    K193622
    Device Name
    TRIOCLEAR System
    Date Cleared
    2021-07-06

    (558 days)

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

    Perfection Aligner System Hong Kong Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TRIOCLEAR System is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movement, it sequentially positions teeth by way of continuous gentle force.
    Device Description
    The TRIOCLEAR System is a removable, non-sterile device intended for single patient use. TRIOCLEAR is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing sets of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.
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