BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Bihelix - soldered

    Reg #: 3007728269 · FEI: 3007728269 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    40
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Digital Dental Laboratories, DBA Orthodent
    Registration Number
    3007728269
    FEI Number
    3007728269
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    311 Viola St.
    City
    Oshawa Ontario
    Country
    CA

    Owner / Operator

    Firm Name
    Digital Dental Laboratories, Inc. DBA Orthodent
    Operator Number
    10028965
    Address
    311 Viola St.
    City
    Oshawa
    State
    Ontario
    Postal Code
    L1H 3A7
    Country
    CA
    Correspondent
    Lori Way

    US Agent

    Business Name
    Johnston's Orthodontic Laboratory
    Contact Name
    Tim Kane
    Address
    92 Bowers Avenue
    City
    Runnemede
    State
    NJ
    ZIP
    08078
    Country
    US
    Email
    [email protected]
    Phone
    856 9395666

    Products

    Device Name Product Code
    Maintainer, Space Preformed, Orthodontic DYT

    Proprietary Names

    Bihelix - soldered Splint - Eclipse Splint - Gelb Splint - Dual Splint - Farrar Band loop space regainer Band loop space maintainer Crozat crib and crescent Splint - Mapa Orthopedic corrector Splint - Day Positioned/Acetal Splint - Biocryl Splint - Witzig/Denar Splint - 2 "C" Clasps Splint - Damon Night Appliance Splint - "B" Splint - Erkoloc Positioner Splint - Remedeeze Splint - 2 Ball Clasps Splint - Day Positioned Appliance Splint - 2 Ball Clasps/Acetal Orthotic - splints Splint - Koise Deprogrammer Splint - Bruxeeze Monoblock Splint - Flexite Splint - Erkoloc Pro Splint - Night Appliance with Nasal Dialator Splint - NTI Splint - Night Appliance Splint - Anterior Deprogrammer Splint - 2 Adams Clasps Splint - SVED/Rick-a-nator Splint - 4 Ball Clasps Marangos tripod splint Splint - no clasps Splint - Compact Day Appliance Splint - Pivot Appliance Splint - Luco

    Establishment Types

    Manufacture Medical Device