Product Classification

• 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 Code: PLH
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Division of Dental and ENT Devices (DHT1B)
• Submission Type: 510(k)
• Regulation Number: 872.5470
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc