Product Classification

• Device: bracket, ceramic, orthodontic
• Regulation Description: Orthodontic plastic bracket.
• Definition: An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new position.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: NJM
• 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

Recognized Consensus Standards

• 4-218 ISO 27020 First edition 2010-12-15
  Dentistry - Brackets and tubes for use in orthodontics
• 4-295 ADA ANSI Standard No. 41-2020
  Evaluation of Biocompatibility of Medical Devices Used in Dentistry
• 4-313 ISO 27020 Second edition 2019-06
  Dentistry - Brackets and tubes 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