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510(k) Data Aggregation
K Number
K201940Device Name
Braces on Demand Bracket
Manufacturer
Braces on Demand, Inc
Date Cleared
2020-12-03
(143 days)
Product Code
DYW, PNN
Regulation Number
872.5470Why 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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