Last synced on 30 September 2022 at 11:05 pm

Mouthguard, Migraine/Tension Headache

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
U
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code OCO is assigned to devices that are "unclassified" (e.g. pre-amendment), it is not linked to any specific regulation and CFR section.

Mouthguard, Migraine/Tension Headache

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
U
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code OCO is assigned to devices that are "unclassified" (e.g. pre-amendment), it is not linked to any specific regulation and CFR section.