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510(k) Data Aggregation

    K Number
    K210540
    Device Name
    Ohlendorf Clear Aligner
    Date Cleared
    2021-05-19

    (84 days)

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

    Ohlendorf Appliance Laboratory

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Ohlendorf Clear Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars). The Ohlendorf Clear Alginer positions teeth by way of continuous gentle force.
    Device Description
    The Ohlendorf Clear Aligner consists of a series of dental-clinician prescribed customized clear plastic removable orthodontic aligner trays that are made from a clear, thin thermoformed polyurethane. A dental clinician prescribes the Ohlendorf Clear Aligner based on an evaluation of the patient's teeth. Either intraoral scans or physical impressions of the patient's teeth are taken, after which the clinician determine course of treatment with the system. The clinician completes a prescription form using standard dental software used for tooth alignment. The series of plastic aligner trays are designed according to the using standard dental software for planning the tooth alignments. The software used is Ortho Analyzer by 3Shape (Reference device K180941). It is used for managing 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements and design of a variety of orthodontic appliances based on 3D scanned orthodontic models. After the plan is developed by Ohlendorf, the prescribing dental clinician reviews and approves the model scheme before the molds are produced. Following approval, Ohlendorf produces the aligner trays. The trays are provided to the dental clinician who provides them to the patient assuring fit and function during the entire treatment period. The clear, thin, thermoplastic polyurethane-polyester composite resin material used for fabrication of the Ohlendorf Clear Aligner is commonly used in many dental and orthodontic appliances, including the predicate clear aligners.
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