Product Classification

• Device: headgear, extraoral, orthodontic
• Regulation Description: Extraoral orthodontic headgear.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: DZB
• 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: 872.5500
• 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

Recognized Consensus Standards

• 4-304 ISO 21606 Second edition 2022-08
  Dentistry - Elastomeric auxiliaries for use in orthodontics
• 4-343 ADA ANSI Standard No. 105-2024
  Elastomeric Auxiliaries for Use in Orthodontics

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