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U.S. Department of Health and Human Services

Product Classification

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Device orthodontic led accessory
Regulation Description Orthodontic plastic bracket.
Definition Intended for use during orthodontic treatment.It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.
Physical State The system consists of a mouthpiece containing LEDs, software, and battery, and a separate storage/charging station.
Technical Method The device functions by applying light energy to the tissue surrouding tooth roots for a photobiomodulation effect.
Target Area Alverolar ridge of maxillary and mandibular arches of patients currently being treated with orthodontic brackets/wires or aligners.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodePLH
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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