BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Candulor brands

    Reg #: 3011511773 · FEI: 3011511773 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Candulor Dental GmbH
    Registration Number
    3011511773
    FEI Number
    3011511773
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Am Riederngraben 6
    City
    Rielasingen-Worblingen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K864707

    Owner / Operator

    Firm Name
    IVOCLAR VIVADENT
    Operator Number
    8010208
    Address
    175 Pineview Dr.
    City
    Amherst
    State
    NY
    Postal Code
    14228
    Country
    US
    Correspondent
    Dana Glina

    US Agent

    Business Name
    Ivoclar Vivadent
    Contact Name
    Anderjeet Gulati
    Address
    175 Pineview Dr.
    City
    Amherst
    State
    NY
    ZIP
    14228
    Country
    US
    Email
    [email protected]
    Phone
    716 2642046

    Products

    Device Name Product Code
    Denture, Plastic, Teeth ELM

    Proprietary Names

    Candulor brands SR Vivodent SR Orthotyp SR Ivostar SR Gnathostar Preference Anterior Preference Posterior SR Vivodent A-D SR Orthotyp A-D

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198