Product Classification

• Device: headgear, extraoral, orthodontic
• Regulation Description: Extraoral orthodontic headgear.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: DZB
• Submission Type: 510(k)
• Regulation Number: 872.5500
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 5832-1:2007 Implants for surgery -- Metallic materials -- Part 1: Wrought stainless steel
• ISO 5832-9:2007 Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.