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U.S. Department of Health and Human Services

Product Classification

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Device orthodontic vibratory accessory
Regulation Description Orthodontic plastic bracket.
Definition An orthodontic accessory intended for use during orthodontic treatment.It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement.
Physical State The system consists of four components: The Activator, Mouthpiece, Charging Port, and Travel Shell.
Technical Method The device functions by providing vibration to the teeth. This is done for 20 minutes a day per the length of the entire treatment.
Target Area Patients with "separate canine retraction" and "en masse" retraction.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeOYH
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type 510(k)
Regulation Number 872.5470
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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