BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    SimpliCore Obturator for Zenflex One

    Reg #: 8030637 · FEI: 3002807826 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Ormex S. de R.L. de C.V.
    Registration Number
    8030637
    FEI Number
    3002807826
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    CALLE 21, No. 1103, AMPLIACION, CIUDAD IND.
    City
    YUCATAN UMAN
    Country
    MX

    Owner / Operator

    Firm Name
    SYBRON DENTAL SPECIALTIES, INC.
    Operator Number
    9029565
    Address
    1717 W. Collins Ave. Ca. 92867 USA, --
    City
    Orange
    State
    CA
    Postal Code
    92867
    Country
    US

    US Agent

    Business Name
    Sybron Dental Specialties Inc.
    Contact Name
    Procoro Herrera
    Address
    200 S. Kraemer Blvd.
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US
    Email
    [email protected]
    Phone
    657 3416074

    Products

    Device Name Product Code
    Gutta-Percha EKM

    Proprietary Names

    SimpliCore Obturator for Zenflex One SimpliCore Obturator Universal K3XF Gutta Percha Elements Gutta Percha Cartridge TF Adaptive Gutta Percha TF Adaptive Obturator Gutta Percha Cartridge TF Adaptive Verifiers SoftCore Gutta Percha Zenflex Pre-Tip Gutta Percha ZenFlex ONE Gutta Percha TF Gutta Percha K3 Gutta Percha Autofit Gutta Percha SimpliFill Apical Plugs Autofit Backfill Gutta Percha

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)