BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Essix (Sports) Mouthguard

    Reg #: 1036212 · FEI: 1036212 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    Dentsply Sirona Orthodontics Inc.
    Registration Number
    1036212
    FEI Number
    1036212
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7290 26th Court East
    City
    Sarasota
    State
    FL
    ZIP
    34243
    Country
    US

    Regulatory Submissions

    510(k) Number
    K062828

    Owner / Operator

    Firm Name
    DENTSPLY SIRONA INC
    Operator Number
    2511302
    Address
    221 WEST PHILADELPHIA ST., SUITE 60W
    City
    York
    State
    PA
    Postal Code
    17401
    Country
    US

    Products

    Device Name Product Code
    Mouthguard, Prescription MQC
    Crown And Bridge, Temporary, Resin EBG
    Aligner, Sequential NXC
    Positioner, Tooth, Preformed KMY

    Proprietary Names

    Essix (Sports) Mouthguard Essix Tray-Rite Tray Material Essix Dual Laminates Essix A+ Essix PLUS Nightguard Laminate (M); Essix Nightguard Laminate Essix C+ Essix ACE

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device