BEUDAMED
    FDA Registration Active 🇫🇷 France

    Itena Clinical Villepinte

    Reg #: 3013557697 · FEI: 3013557697 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    12

    Registration Details

    Registration Name
    Itena Clinical Villepinte
    Registration Number
    3013557697
    FEI Number
    3013557697
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    97 Allee de la Louve
    City
    Villepinte Seine-Saint-Denis
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K122551

    Owner / Operator

    Firm Name
    ITENA Clinical
    Operator Number
    10045822
    Address
    Central Parc Batiment B, 97 Allee de la Louve
    City
    Villepinte
    State
    Ile-de-France
    Postal Code
    93420
    Country
    FR
    Correspondent
    Alexandra PETIT

    US Agent

    Business Name
    LOK USA, Inc.
    Contact Name
    Marilyne Joly
    Address
    2915 Ogletown Rd
    City
    Newark
    State
    DE
    ZIP
    19713
    Country
    US
    Email
    [email protected]
    Phone
    412 2851076

    Products

    Device Name Product Code
    Cement, Dental EMA
    Post, Root Canal ELR
    Agent, Tooth Bonding, Resin KLE
    Disk, Abrasive EHJ
    Sealant, Pit And Fissure, And Conditioner EBC
    Resin, Root Canal Filling KIF
    Applicator, Resin KXR
    Drill, Dental, Intraoral DZA
    Handle, Instrument, Dental EJB
    Material, Tooth Shade, Resin EBF
    Point, Abrasive EHL
    Wheel, Polishing Agent EJQ

    Proprietary Names

    CEMENT, DENTAL ROOT CANAL AGENT, TOOTH BONDING, RESIN DISK, ABRASIVE EBC / SEALANT, PIT AND FISSURE, AND CONDITIONER RESIN, ROOT CANAL FILLING APPLICATOR, RESIN DRILL, DENTAL, INTRAORAL HANDLE, INSTRUMENT, DENTAL Material, tooth shade, resin POINT, ABRASIVE WHEEL, POLISHING AGENT

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Foreign Private Label Distributor