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510(k) Data Aggregation

    K Number
    K212496
    Device Name
    Ortho Aligner System
    Manufacturer
    Ortho Lab Services, LLC
    Date Cleared
    2021-11-04

    (87 days)

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

    Ortho Lab Services, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ortho Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Ortho Aligner System positions teeth by way of continuous gentle force.
    Device Description
    The Ortho Aligner System is comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. The aligners are provided non-sterile and are customized for each patient according to the dental practitioner's prescription. Physical impressions or digital intraoral scans of the patient's teeth are provided to Ortho Lab Services. A treatment plan consisting of 3D models is created from the impressions or scans, by Ortho Lab Services using the OrthoWare software. Upon approval of the treatment plan by the treating dental practitioner using OrthoPortal and issuance of an electronic prescription, the clear aligners are manufactured using thermoforming methods. The finished, customized aligners are shipped based on the dental practitioner's order and confirmed for patient fit and design. The aligner trays are held in place by pressure and can be removed by the patient at any time.
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