BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Night Guard

    Reg #: 3017567754 · FEI: 3017567754 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    3DPX MEDICAL
    Registration Number
    3017567754
    FEI Number
    3017567754
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    410 N Milwaukee Ave Suite 100
    City
    Chicago
    State
    IL
    ZIP
    60607
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230495

    Owner / Operator

    Firm Name
    3DPX Medical
    Operator Number
    10078770
    Address
    410 N Milwaukee Ave Suite 100
    City
    Chicago
    State
    IL
    Postal Code
    60654
    Country
    US
    Correspondent
    Sarah Moss

    Products

    Device Name Product Code
    Mouthguard, Migraine/Tension Headache OCO
    Mouthguard, Prescription MQC

    Proprietary Names

    Night Guard

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)