BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    3Shape A/S

    Reg #: 3005940400 · FEI: 3005940400 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    52
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    3Shape A/S
    Registration Number
    3005940400
    FEI Number
    3005940400
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Holmens Kanal 7
    City
    Copenhagen Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K202256

    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
    System, Image Processing, Radiological LLZ
    Dental Abutment Design Software For Dental Laboratory PNP
    Orthodontic Software PNN
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
    Mouthguard, Prescription MQC

    Proprietary Names

    Implant Studio Abutment Design Ortho System 3Shape Splint Design Trios 6 3D scanner R500 3D Scanner R700 3D scanner D900L 3D scanner R710 3D scanner R900 3D Scanner R750 3D Scanner D750 3D Scanner R850 3D Scanner R1000 3D Scanner R2000 3D Scanner D1000 3D Scanner D850 3D Scanner D2000 3Shape Anatomy Design E1 scanner E2 Scanner Novux E3 Scanner Novux E1 Scanner Novux D850 Novux D750 Novux D2000 3Shape Dental System TRIOS Scanner E3 Scanner Novux E2 Scanner E4 Scanner TRIOS 3 Wireles TRIOS 4 Trios Interoral Dental System Puffin TRIOS Patient Monitoring Novux E4 Scanner 3D Scanner D700 3D scanner D710 Automate 3D Scanner D800 3D Scanner D810 3D scanner D500 3Shape F8 Trios Move+ Trios Move Pro Trios 3 3D scanner D900 S1P-2 scanning tip 3Shape Ortho System Abutment designer 3Shape Ortho System Mouthguard

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility