Product Classification

• Device: tongue suspension system
• Regulation Description: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
• Definition: Intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with a suture. It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring.
• Physical State: Bone screw and suture material
• Technical Method: Physical advancement of the tongue.
• Target Area: Oral cavity
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: ORY
• 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: 872.5570
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: Yes
• 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
• 4-294 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

Not Third Party Eligible