Product Classification

• Device: orthodontic software
• Regulation Description: Orthodontic plastic bracket.
• Definition: The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only.
• Physical State: Software which may produce an orthodontic appliance
• Technical Method: May use software, scanning equipment, CAD/CAM, and printing machines for the fabrication of orthodontic appliances
• Target Area: Intraoral
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: PNN
• 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