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510(k) Data Aggregation

    K Number
    K201940
    Device Name
    Braces on Demand Bracket
    Manufacturer
    Braces on Demand, Inc
    Date Cleared
    2020-12-03

    (143 days)

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

    Braces on Demand, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Braces on Demand Bracket is intended for use as a clear, plastic bracket system to provide orthodontic movement of natural teeth.
    Device Description
    The proposed device is a 3D-printed bracket system that directly bonds to either primary teeth, permanent teeth, or mixed dentition to provide for orthodontic treatment for patients with malocclusions. Each bracket is 3D printed using a photopolymer denture resin. The Braces on Demand Bracket System has an integral hook design, which allows for attachment of accessories such as elastics or springs to assist the clinician in producing the desired tooth movement. The hook position on the Braces on Demand brackets can be on the mesial occlusal tiewing or the distal occlusal tiewing, similar to traditional orthodontic brackets. The application and removal of the Braces on Demand brackets are similar to other orthodontic brackets in that it requires orthodontic adhesive for bonding and standard orthodontic tools and techniques for de-bonding. The bonding surface of the bracket is a mechanical dovetail undercut design, allowing the bracket to mechanically retain the adhesive and bond to the facial surface of the tooth.
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