BEUDAMED
    FDA Registration Active 🇺🇸 United States

    3Shape Inc.

    Reg #: 3015193486 · FEI: 3015193486 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    47
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    3Shape Inc.
    Registration Number
    3015193486
    FEI Number
    3015193486
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2800 Perimeter Park Drive, Suite E
    City
    Morrisville
    State
    NC
    ZIP
    27560
    Country
    US

    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

    Products

    Device Name Product Code
    Laser, Fluorescence Caries Detection NBL
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF

    Proprietary Names

    Trios 5 (L1P-1F) 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 L1P-1F

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)