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U.S. Department of Health and Human Services

Product Classification

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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 CodeOCO
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Unclassified Reason Pre-Amendment
Submission Type 510(k)
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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