BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    ODNE AG

    Reg #: 3030405669 · FEI: 3030405669 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    ODNE AG
    Registration Number
    3030405669
    FEI Number
    3030405669
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Ringstrasse 14
    City
    Dubendorf Zurich
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K231387

    Owner / Operator

    Firm Name
    Odne AG
    Operator Number
    10089937
    Address
    Ringstrasse 14
    City
    Dübendorf
    State
    Zurich
    Postal Code
    8600
    Country
    CH
    Correspondent
    Mark Bispinghoff

    US Agent

    Business Name
    Odne Inc
    Contact Name
    Andreas Schmocker
    Address
    123 Linden Blvd Apt 17j
    City
    Brooklyn
    State
    NY
    ZIP
    11226
    Country
    US
    Email
    [email protected]
    Phone
    303 9440201

    Products

    Device Name Product Code
    Resin, Root Canal Filling KIF
    Laser Activator For Polymerization QNF
    Scaler, Ultrasonic ELC
    Instrument, Filling, Plastic, Dental EIY

    Proprietary Names

    OdneFill OdneCure OdneCure Tip OdneClean Tip OdneClean OdneFill Tip

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility