BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    3Shape Ortho System Mouthguard

    Reg #: 3005940400 · FEI: 3005940400 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    3Shape A/S
    Registration Number
    3005940400
    FEI Number
    3005940400
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Holmens Kanal 7
    City
    Copenhagen Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K161884

    Owner / Operator

    Firm Name
    3Shape A/S
    Operator Number
    10023901
    Address
    Holmens Kanal 7
    City
    Copenhagen K
    State
    Hovedstaden
    Postal Code
    1060
    Country
    DK
    Correspondent
    David Rothkopf

    US Agent

    Business Name
    MEDIcept
    Contact Name
    David Rothkopf
    Address
    200 Homer Ave
    City
    Ashland
    State
    MA
    ZIP
    01721
    Country
    US
    Email
    [email protected]
    Phone
    508 2318842 ext. 20

    Products

    Device Name Product Code
    Mouthguard, Prescription MQC

    Proprietary Names

    3Shape Ortho System Mouthguard

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility