BEUDAMED
    FDA Registration Active 🇺🇸 United States

    3shape inc

    Reg #: 3010728558 · FEI: 3010728558 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    53
    Establishment Types
    1
    Classifications
    5

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    Registration Details

    Registration Name
    3shape inc
    Registration Number
    3010728558
    FEI Number
    3010728558
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    430 Mountain Avenue, Suite 205
    City
    New Providence
    State
    NJ
    ZIP
    07974
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221249

    Owner / Operator

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

    Products

    Device Name Product Code
    Laser, Fluorescence Caries Detection NBL
    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

    Proprietary Names

    L1P-1F Implant Studio Trios 5 (L1P-1F) Abutment designer 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 Abutment Design 3Shape Ortho System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198