BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Alpen Ceramic Plus ShapeGuard

    Reg #: 2416455 · FEI: 2416455 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    51
    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
    Wheel, Polishing Agent EJQ

    Proprietary Names

    Alpen Ceramic Plus ShapeGuard Alpen Composite Plus ShapeGuard Alpen Zirconia Plus ShapeGuard Alpen Polishers Jiffy Disks Jiffy Points Jiffy HiShine Points Disposable KENDA Composite Microfill Jiffy HiShine Cups Disposable KENDA Unicus KENDA Nobilis Disposable KENDA Hybrid KENDA Unicus KENDA Composite Microfill KENDA POLISHERS KENDA Deluxe Disposable KENDA Prophy KENDA Prophy Jiffy Cups KENDA Diagum KENDA point, abrasive Jiffy HiShine Disks KENDA Maximus KENDA All Ceramic Disposable KENDA Nobilis KENDA Complete KENDA Precious Metals KENDA C.G.I. KENDA Amalgam KENDA Hybrid KENDA Planus KENDA FG Series Disposable KENDA C.G.I. Disposable KENDA Big Job Disposable KENDA G.P.S. KENDA Zircovis KENDA Nobilis & Unicus KENDA Microfill KENDA Acrylic Blue KENDA Yellow Line Kenda ECO Line Removers Kenda ECO Line Smoothers KENDA Queen KENDA High End KENDA Bestflex KENDA RED Kenda ECO Line Polishers KENDA Wheel & Knife Kenda Polishette KENDA Zirco1 KENDA Z-Series

    Establishment Types

    Repack or Relabel Medical Device