BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hygenic® Bite Wafers, Soft, Yellow

    Reg #: 2416455 · FEI: 2416455 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    COLTENE/WHALEDENT INC.
    Registration Number
    2416455
    FEI Number
    2416455
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    235 Ascot Pkwy
    City
    CUYAHOGA FALLS
    State
    OH
    ZIP
    44223
    Country
    US

    Owner / Operator

    Firm Name
    Coltene/Whaledent AG
    Operator Number
    9089944
    Address
    Altstaetten, Feldwiesenstrasse 20
    City
    Altstaetten
    State
    Sankt Gallen
    Postal Code
    CH 9450
    Country
    CH

    Products

    Device Name Product Code
    Wax, Dental, Intraoral EGD

    Proprietary Names

    Hygenic® Bite Wafers, Soft, Yellow Hygenic® Medium-Soft No. 3 Pink Wax Boxing Wax Hygenic® Square Wax Ropes Hygenic® Bite Wafers Hygenic® Round Wax Strips Hygenic® Bite Wafers, Extra, Hard, Green Plastic Wax Sticks Hygenic® Bite Wafers, Laminated, Blue Hygenic® Occlusal Rim Wax Hygenic® Red Wax Hygenic® Orthodontic Tray Wax Extra Tough Wax Yellow Bite Wax Hygenic® Orthodontic Tray Wax Sticks

    Establishment Types

    Manufacture Medical Device