BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Biodentine

    Reg #: 3002807757 · FEI: 3002807757 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    NOVOCOL PHARMACEUTICAL OF CANADA, INC.
    Registration Number
    3002807757
    FEI Number
    3002807757
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    25 Wolseley Court
    City
    Cambridge Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K140132

    Owner / Operator

    Firm Name
    Novocol Pharmaceutical of Canada, Inc.
    Operator Number
    10048017
    Address
    25 Wolseley Court
    City
    Cambridge
    State
    Ontario
    Postal Code
    N1R 6X3
    Country
    CA

    Products

    Device Name Product Code
    Resin, Root Canal Filling KIF
    Cement, Dental EMA

    Proprietary Names

    Biodentine

    Establishment Types

    Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device