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510(k) Data Aggregation
K Number
K142729Device Name
Chi Lites Orthodontic Sapphire Bracket
Manufacturer
Date Cleared
2015-05-15
(234 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
PROGRESSIVE TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Progressive Technology Inc. Chi Lites Orthodontic Sapphire Bracket is a line of single-use devices intended for orthodontic movement of teeth. The bracket is used temporarily and is removed upon completion of orthodontic treatment.
Device Description
Progressive Technology Inc. is submitting this Premarket Notification for its Class II product, an orthodontic sapphire bracket. The device is intended for use in conjunction with comprehensive orthodontics to control the movement of individual teeth. The brackets are comprised of several geometries that vary from bracket to bracket, corresponding to the intended tooth. These geometries contribute to the fit of the bracket to the tooth and also impart the axial control of the energy from the archwire.
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