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 |
Division of Dental and ENT Devices
(DHT1B)
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
|
Third Party Review |
Not Third Party Eligible |