BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    3SHAPE TRIOS A/S

    Reg #: 3009560013 · FEI: 3009560013 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    15
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    3SHAPE TRIOS A/S
    Registration Number
    3009560013
    FEI Number
    3009560013
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Holmens Kanal 7
    City
    copenhagen Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K242103

    Owner / Operator

    Firm Name
    3Shape Trios
    Operator Number
    10040244
    Address
    Holmens Kanal 7
    City
    copenhagen
    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
    617 8993449

    Products

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

    Proprietary Names

    Trios Ready Tip Trios 5 (L1P-1F) L1P-1F TRIOS 3 Wireless TRIOS 4 TRIOS Patient Monitoring Trios Interoral Dental System Trios Move+ 3Shape F8 S1P-2 scanning tip Trios 6 Trios 3 Trios Move Pro Trios Core Trios Dx

    Establishment Types

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