BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Dentek Platinum Ultimate Comfort Dental Guard

    Reg #: 1719513 · FEI: 1719513 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MEDTECH PRODUCTS, INC.
    Registration Number
    1719513
    FEI Number
    1719513
    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
    K123849

    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 Platinum Ultimate Comfort Dental Guard Dentek New Comfort-Fit Dental Guard

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility