BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Dentek Fresh Protect Dental Guard

    Reg #: 2938386 · FEI: 2938386 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DenTek Oral Care, Inc.
    Registration Number
    2938386
    FEI Number
    2938386
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    660 white plains rd, --
    City
    Tarrytown
    State
    NY
    ZIP
    10591
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202974

    Owner / Operator

    Firm Name
    PRESTIGE BRANDS HOLDINGS, INC.
    Operator Number
    9057674
    Address
    660 White Plains Rd, --
    City
    Tarrytown
    State
    NY
    Postal Code
    10591
    Country
    US
    Correspondent
    Czarina - Ochoa

    Products

    Device Name Product Code
    Mouthguard, Over-The-Counter OBR

    Proprietary Names

    Dentek Fresh Protect Dental Guard

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility