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510(k) Data Aggregation
K Number
K170093Device Name
AcceleDent Optima
Manufacturer
Date Cleared
2017-05-26
(135 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
OrthoAccel Technology Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
AcceleDent® Optima is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.
Device Description
The AcceleDent® Optima is an orthodontic accessory for the treatment of tooth malocclusion. AcceleDent® Optima should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment.
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