BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Doctor's® NightGuard Advanced Comfort

    Reg #: 2529596 · FEI: 1000121324 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Moldgenix LLC
    Registration Number
    2529596
    FEI Number
    1000121324
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    354 East Broad Street
    City
    Trumbauersville
    State
    PA
    ZIP
    18970
    Country
    US

    Regulatory Submissions

    510(k) Number
    K073220

    Owner / Operator

    Firm Name
    Moldgenix LLC
    Operator Number
    10090559
    Address
    354 East Broad Street, PO Box 878
    City
    Trumbauersville
    State
    PA
    Postal Code
    18970
    Country
    US
    Correspondent
    Thomas Houdeshell

    Products

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

    Proprietary Names

    Doctor's® NightGuard Advanced Comfort

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)