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510(k) Data Aggregation

    K Number
    K151965
    Device Name
    Dentti System
    Manufacturer
    Date Cleared
    2016-03-11

    (239 days)

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

    Martz, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dentti System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
    Device Description
    The Dentti System is a series of clear plastic aligners that are used to replace traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligners moves the teeth gently, and in small increments, from their original to their final treated position for improved dental alignment. The Dentist will provide a scan of the patient's current dentition along with instructions for the treatment plan. The dental laboratory will generate a series of 3-D computer-designs of the modified dentition that the Dentist will review. Upon approval, the models will be generated and used to fabricate the sequential aligners according to the dentist's prescription. The aligners are fabricated from commonly used thermoformed polyurethane plastic material. The aligners are sent back to the Dentist, who then provides them to the patient, confirming the fit and design. Over a period of months, additional aligners will be provided sequentially to the patient by the Dentist to gradually move the selected teeth to the desired position. The Dentist will monitor the treatment from the moment the first aligner is delivered to when treatment is completed. The aligners are held in place by pressure and can be removed by the patient at any time. This technology is essentially identical to that used by a number of sequential alignment systems, including the predicate devices.
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