BEUDAMED
    Product Code: OCO FDA unclassified

    Mouthguard, Migraine/Tension Headache

    Unknown

    The Migraine/Tension Headache Mouthguard (product code OCO) is a dental device used prophylactically for the treatment of medically diagnosed migraine pain and migraine-associated tension-type headaches by reducing trigeminally innervated muscular activity; it is also indicated for the prevention of bruxism and TMJ syndrome. The device works by mechanically reducing jaw muscle activity that contributes to headache and bruxing patterns. This device is FDA Unclassified (class U) with no assigned regulation number or medical specialty, pending classification, with an unclassified reason code indicating ongoing review. It carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    3
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    3
    Years Active
    20

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    Basic Information

    Product Code
    OCO
    Device Class
    FDA unclassified
    Medical Specialty
    Unknown
    Review Panel
    DE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    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.

    Unclassified Reason

    1

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K202523 TMJ Relax
    K160477 The Luco Hybrid OSA Appliance
    K010876 NTI TENSION SUPPRESSION SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.