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510(k) Data Aggregation

    K Number
    K192338
    Device Name
    NEOLab Clear Aligners
    Date Cleared
    2020-03-12

    (197 days)

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

    New England Ortho Lab, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    NEOLab Clear Aligners are indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). The NEOLab Clear Aligners position teeth through the use of continuous gentle force.
    Device Description
    NEOLAB Clear Aligners consist of a series of customized clear plastic removable aligners that are fabricated from a clear, thin thermoformed polyurethane. The aligners are designed to gradually move the patient's teeth incrementally, repositioning them from their original misalignment to a more aligned state. The aligners, customized for each patient's prescription, are designed and manufactured based on either standard impressions or intraoral scans taken by the dental clinician and which are then sent to the company. The aligners are then sent back to the dental clinician who then distributes them in sequential stages to the patient and follows up with the patient through orthodontic examinations to check device fit and function. During manufacturing, models are made from physical impressions or intraoral scans. Those made from stone or plaster impressions are scanned into the computer and made into digital files. The intraoral scans arrive as digital files. The digital files are 3D printed and are used to produce the aligner series with the thermoplastic polyurethane. The thermoplastic material used for fabrication of the aligners is commonly used in many dental appliances, including the predicate aligners.
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