Product Classification

• 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 Code: OYH
• Premarket Review: Division of Dental and ENT Devices (DHT1B); 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