BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LunaGuard Nighttime Dental Guard

    Reg #: 1818945 · FEI: 1818945 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MCKEON PRODUCTS, INC.
    Registration Number
    1818945
    FEI Number
    1818945
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    25460 GUENTHER
    City
    WARREN
    State
    MI
    ZIP
    48091
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191033

    Owner / Operator

    Firm Name
    MCKEON PRODUCTS, INC.
    Operator Number
    1818945
    Address
    25460 GUENTHER, --
    City
    Warren
    State
    MI
    Postal Code
    48091
    Country
    US
    Correspondent
    DEVIN - BENNER

    Products

    Device Name Product Code
    Mouthguard, Over-The-Counter OBR

    Proprietary Names

    LunaGuard Nighttime Dental Guard

    Establishment Types

    Repack or Relabel Medical Device