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510(k) Data Aggregation

    K Number
    K143499
    Device Name
    eCligner
    Date Cleared
    2015-10-09

    (303 days)

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

    eClear International Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    eCligner® is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). The eCligner® is intended for minor anterior tooth movement by way of continuous gentle force.
    Device Description
    eCligner® is a transparent and removable orthodontic appliance. eCligner® is a digitally- made Clear Aligner by the 3DCAD/CAM system. By printing the completed setup data into a series of plastic models, eCligne® is produced by a simple stamping procedure (Vacuum forming). eCligner® is designed for orthodontic tooth movement. Each step for using orthodontic appliance, eCligner® consists of 3 weeks (1 week for soft, 1 week for medium and 1 week for hard) and wearing the appliance 17 hours a day for each sequence is required. * More than 3 weeks of wearing may be required per step depending on the direction of orthodontic treatment and dentist's instruction. * eCligner® -H is used for 3 weeks during Final process. During one individual step of treatment, three aligners of different layer thickness are worn in weekly intervals. The applied layer thicknesses are 0.5 mm (medium) and 0.75 mm (hard). Each individual step is consisting of three different thickness appliances as follows: 1. eCligner® -S (Soft) 2. eCligner® -M (Medium) 3. eCligner® -H (Hard) *eCligner® -UH (Ultra Hard, 1.00mm) is used only for the patient with Bruxism (Teeth Grinding) since the aligner can be broken while the patient grinds their teeth unintentionally.
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