BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    SR ORTHOPLANE DCL

    Reg #: 3009496224 · FEI: 3009496224 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IVOCLAR VIVADENT, INC.
    Registration Number
    3009496224
    FEI Number
    3009496224
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1-6600 Dixie Road
    City
    Mississauga Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K962456

    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

    SR ORTHOPLANE DCL SR Orthotyp DCL Candulor brand denture teeth SR VIVODENT DCL SR ORTHOLINGUAL DCL Candulor Bonartic TCR Candulor Physioset TCR BlueLine

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device