Product Classification

• Device: mouthguard, migraine/tension headache
• Definition: A device to be used in the prophylactic treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches, by reducing their signs and symptoms through reduction of trigeminally innervated muscular activity, and; For the prevention of bruxism and tmj syndrome through reduction of trigeminally innervated muscular activity.
• Physical State: Plastic mouthguard fitted to the teeth
• Technical Method: Mouthguard repositions the jaw to reduce muscle tension
• Target Area: Oral cavity
• Review Panel: Dental
• Product Code: OCO
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Division of Dental and ENT Devices (DHT1B)
• Unclassified Reason: Pre-Amendment
• Submission Type: 510(k)
• Device Class: Unclassified
• 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
• 4-254 ADA ANSI Standard No. 99-2001 (R2023)
  Athletic Mouth Protectors and Materials
• 4-294 ADA ANSI Standard No. 139-2020
  Dental Base Polymers

Third Party Review

Not Third Party Eligible