Product Classification

• Device: device, jaw repositioning
• Regulation Description: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: LQZ
• Premarket Review: Division of Dental and ENT Devices (DHT1B); Division of Dental and ENT Devices (DHT1B)
• Submission Type: 510(k)
• Regulation Number: 872.5570
• 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

• 4-233 ISO 20795-2 Second edition 2013-03-01
  Dentistry - Base polymers - Part 2: Orthodontic base polymers
• 4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12
  Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
• 4-268 ISO 15841 Second edition 2014-08
  Dentistry - Wires for use in orthodontics [Including AMENDMENT 1 (2020)]
• 4-294 ADA ANSI Standard No. 139-2020
  Dental Base Polymers
• 4-295 ADA ANSI Standard No. 41-2020
  Evaluation of Biocompatibility of Medical Devices Used in Dentistry

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc