BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    COLTENE/WHALEDENT AG

    Reg #: 9613375 · FEI: 3002806620 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    125
    Establishment Types
    2
    Classifications
    13

    Registration Details

    Registration Name
    COLTENE/WHALEDENT AG
    Registration Number
    9613375
    FEI Number
    3002806620
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    FELDWIESENSTRASSE 20
    City
    ALTSTAETTEN Sankt Gallen
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K840085

    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

    US Agent

    Business Name
    Coltene/Whaledent Inc
    Contact Name
    Tricia Cregger
    Address
    235 Ascot Parkway
    City
    Cuyahoga Falls
    State
    OH
    ZIP
    44223
    Country
    US
    Email
    [email protected]
    Phone
    330 9168904

    Products

    Device Name Product Code
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Material, Tooth Shade, Resin EBF
    Material, Impression ELW
    Agent, Tooth Bonding, Resin KLE
    Crown And Bridge, Temporary, Resin EBG
    Wheel, Polishing Agent EJQ
    Cement, Dental EMA
    Point, Abrasive EHL
    Accessories, Retractor, Dental EIF
    Instrument, Diamond, Dental DZP
    Syringe, Restorative And Impression Material EID
    Disk, Abrasive EHJ
    Bur, Dental EJL

    Proprietary Names

    Biosonic Suvi Air Polishing Powder Jiffy Disks Jiffy HiShine Cups Jiffy Points Jiffy HiShine Points Jiffy Cups Jiffy HiShine Disks KENDA DENTAL POLISHERS SDI Polishers C.G.I. SDI Polishers Diamond Brilliant Jet Blue Bite BRILLIANT EverGlow Magic FoamCord BRILLIANT Crios Rapid One Coat 7 Universal One Coat 7 Universal, One Coat 7, One Coat 7 Activator Cool Temp Natural Alpen Composite Plus ShapeGuard Alpen Ceramic Plus ShapeGuard Alpen Zirconia Plus ShapeGuard Alpen Polishers Disposable KENDA Nobilis KENDA C.G.I. KENDA Amalgam KENDA Unicus KENDA Nobilis KENDA Zircovis KENDA FG Series Disposable KENDA Big Job Disposable KENDA Prophy KENDA Complete Disposable KENDA C.G.I. KENDA Prophy KENDA Diagum KENDA Planus Disposable KENDA Hybrid Disposable KENDA Composite Microfill KENDA POLISHERS KENDA Composite Microfill KENDA point, abrasive KENDA All Ceramic KENDA Hybrid Disposable KENDA Unicus KENDA Precious Metals KENDA Deluxe KENDA Maximus Disposable KENDA G.P.S. KENDA RED KENDA Microfill KENDA Wheel & Knife Kenda ECO Line Smoothers KENDA Bestflex Kenda ECO Line Removers Kenda ECO Line Polishers KENDA Z-Series KENDA Acrylic Blue KENDA Nobilis & Unicus KENDA High End KENDA Zirco1 KENDA Queen KENDA Yellow Line Kenda Polishette DUO TEMP A.R.T. Bond Coltosol F Diatech, SwissTEC, SwissBurs KENDA Dental Polishers Miris Brilliant New Line Brilliant NG Synergy D6 Synergy Nano Formula Synergy Synergy Flow Brilliant Flow Synergy D6 Flow COMPONEER Class V COMPONEER Brilliant COMPONEER POLISHER+BURR CADDY KENDA Practicus AUTOCLAVABLE Polisher & bur caddy Diatech Diamond Instruments Alpen Diamond Instruments Alpen Alpen Speedster Zr Plus DIATECH Z-Rex DIATECH Alpen Z-Rex Tip Dispenser TempoSIL 2 Diatech, SwissTEC Disks BRILLIANT EverGlow Flow BRILLIANT Bulk Fill Flow Speedex Coltex Coltoflax President ParaPost ParaCore automix ParaCore DuoCem ALPEN SPEEDSTER Diatech Carbide SimplePrep Alpen® SteriX Alpen® Carbide Fill-Up! PRESIDENT The Original One Coat Self-Etching Bond One Coat 7 SoloCem One Coat Bond SL NE Total Etch Bond 5ml NE Self Etch Bond Plus 5ml One Coat Bond ParaCem Universal DC President Plus HydroXtreme AFFINIS President Jet light / regular body President Plus Jet Jet Bite

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)