BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GERGENS ORTHODONTIC LAB

    Reg #: 3008274496 · FEI: 3008274496 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    GERGENS ORTHODONTIC LAB
    Registration Number
    3008274496
    FEI Number
    3008274496
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1745 West Deer Valley Rd, Suite 112
    City
    Phoenix
    State
    AZ
    ZIP
    85027
    Country
    US

    Regulatory Submissions

    510(k) Number
    K113126

    Owner / Operator

    Firm Name
    Gergens Orthodontic Lab
    Operator Number
    10031363
    Address
    1745 W Deer Valley Rd Suite 112
    City
    Phoenix
    State
    AZ
    Postal Code
    85027
    Country
    US
    Correspondent
    David S Gergen

    Products

    Device Name Product Code
    Device, Anti-Snoring LRK
    Wire, Orthodontic DZC
    Device, Jaw Repositioning LQZ

    Proprietary Names

    mRNA Appliance Vivos DNA Appliance Acylic Herbst TAP mmRNA appliance

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device