BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Enamelize™

    Reg #: 3002789526 · FEI: 3002789526 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DELTAMED GMBH
    Registration Number
    3002789526
    FEI Number
    3002789526
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    RAIFFEISENSTR. 8a
    City
    FRIEDBERG Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K862912

    Owner / Operator

    Firm Name
    DELTAMED GMBH
    Operator Number
    9026386
    Address
    RAIFFEISENSTR. 8a, --
    City
    FRIEDBERG
    State
    Hesse
    Postal Code
    61169
    Country
    DE

    US Agent

    Business Name
    COSMEDENT, INC.
    Contact Name
    Mary Beth Nowak
    Address
    401 NORTH MICHIGAN AVE., SUITE 2500
    City
    CHICAGO
    State
    IL
    ZIP
    60611
    Country
    US
    Email
    [email protected]
    Phone
    800 6216729

    Products

    Device Name Product Code
    Agent, Polishing, Abrasive, Oral Cavity EJR

    Proprietary Names

    Enamelize™

    Establishment Types

    Manufacture Medical Device