BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Trios 5 (L1P-1F)

    Reg #: 3015193486 · FEI: 3015193486 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    3Shape Inc.
    Registration Number
    3015193486
    FEI Number
    3015193486
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2800 Perimeter Park Drive, Suite E
    City
    Morrisville
    State
    NC
    ZIP
    27560
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242103

    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

    Proprietary Names

    Trios 5 (L1P-1F)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)