BEUDAMED
    FDA Registration Active 🇺🇸 United States

    COLTENE/WHALEDENT INC.

    Reg #: 2416455 · FEI: 2416455 · Expires 2026
    View on FDA
    Products
    34
    Proprietary Names
    207
    Establishment Types
    5
    Classifications
    34

    Registration Details

    Registration Name
    COLTENE/WHALEDENT INC.
    Registration Number
    2416455
    FEI Number
    2416455
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    235 Ascot Pkwy
    City
    CUYAHOGA FALLS
    State
    OH
    ZIP
    44223
    Country
    US

    Regulatory Submissions

    510(k) Number
    K040551

    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
    Needle, Dental DZM
    Cleaner, Ultrasonic, Medical Instrument FLG
    Bur, Dental EJL
    Wax, Dental, Intraoral EGD
    Frame, Rubber Dam EJE
    Activator, Ultraviolet, For Polymerization EBZ
    Locator, Root Apex LQY
    Handle, Instrument, Dental EJB
    Drill, Dental, Intraoral DZA
    Disinfectant, Medical Devices LRJ
    Dam, Rubber EIE
    Agent, Polishing, Abrasive, Oral Cavity EJR
    File, Pulp Canal, Endodontic EKS
    Accessories, Implant, Dental, Endosseous NDP
    Scaler, Ultrasonic ELC
    Pin, Retentive And Splinting, And Accessory Instruments EBL
    Cleanser, Root Canal KJJ
    Wheel, Polishing Agent EJQ
    Post, Root Canal ELR
    Tray, Impression, Preformed EHY
    Resin, Root Canal Filling KIF
    Clamp, Rubber Dam EEF
    Absorber, Saliva, Paper KHR
    Preparer, Root Canal Endodontic EKQ
    Unit, Electrosurgical, And Accessories, Dental EKZ
    Tester, Pulp EAT
    Sterilizer, Dry Heat KMH
    Syringe, Periodontic, Endodontic, Irrigating EIC
    Instruments, Dental Hand DZN
    Handpiece, Direct Drive, Ac-Powered EKX
    Instrument, Diamond, Dental DZP
    Strip, Polishing Agent EHM
    Dispenser, Liquid Medication KYX
    Forceps, Rubber Dam Clamp EJG

    Proprietary Names

    CanalPro Irrigating Tips Biosonic® Ultrasonic Cleaners BioSonic UC32 BioSonic UC30 StatClean Dentronix MP-US Plus BioSonic UC31 ALPEN SPEEDSTER Diatech Carbide SimplePrep Alpen® SteriX Alpen® Carbide Hygenic® Bite Wafers Hygenic® Bite Wafers, Soft, Yellow Hygenic® Round Wax Strips Extra Tough Wax Hygenic® Red Wax Yellow Bite Wax Hygenic® Orthodontic Tray Wax Hygenic® Orthodontic Tray Wax Sticks Hygenic® Occlusal Rim Wax Hygenic® Bite Wafers, Extra, Hard, Green Hygenic® Bite Wafers, Laminated, Blue Plastic Wax Sticks Boxing Wax Hygenic® Square Wax Ropes Hygenic® Medium-Soft No. 3 Pink Wax Dental Dam Frame COLTOLUX LED CURING LIGHT Endocater DENTAL DAM PUNCH ParaPost® Taper Lux Drills Max® Drills ParaPost® Fiber Lux Drills Kodex® Drills Unity® Drills ParaPost® XH Drills ParaPost® Drills Bondent® Drills ParaPost® X Drills ParaPost® XP Drills ParaPost® XT Drills Starter Drill Ultronics Ultracare BioSonic UC42 Hygenic® Elasti-Dam Hygenic® Flexi Dam Hygenic® Fiesta® Dental Dam Hygenic® Dental Dam Kits 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 ROEKO Dental Dam CanalPro One curve 2Shape R-ENDO ONE CURVE STARTER PACK ONE-G HERO SHAPER MicroMega REMOVER HERO 642 2Shape Procedure Pack HyFlex™ CM HEDSTROEM FILES K FILES H-Files ONE FLARE HYFLEX REMOVER ONE CURVE PROCEDURE PACK MME Files HEDSTROEM FILES Prime Line K FILES Prime Line REMOVER MMC FILES K-Files MicroMega One Reci Procedure Pack 2 Shape Mini MicroMega One Curve Mini 2 Shape Mini Procedure Pack MicroMega One Curve Mini Procedure Pack MicroMega One Reci MM K-Files, MM H-Files, MM K-Reamers MicroMega Reci Glider MM TAPER MicroMega One Glider Proxima (Procma) Saw Blades Pindex System & Accessories Accutrac Die System Including: Accessories, Kits, BioSonic S1 Piezo Scaler TMS Link Plus® TMS Link® Minikin Max® Restorative Pins TMS® Minuta TMS® Regular TMS Link® Minim TMS® Minikin Unity® Restorative Pins TMS Link Plus® Regular Bondent® Dentin Bonding Pins TMS Link Plus® Minim TMS Link® Minuta TMS Link® Regular TMS® Minim CanalPro CHX-Ultra 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 TENAX WHITE POST PRESIDENT TRAY Dental Endodontic Cement Mod. Hygenic® Gloss Finish Wingless Clamps Hygenic® Dental Dam Clamps Hygenic® Dental Dam Clamp-Sets Hygenic® Fiesta® Color Coded Matte Finish Winged Clamps Hygenic® Gloss Finish Winged Clamps Hygenic® Fiesta® Color Coded Matte Finish Clamps Hygenic® Fiesta® Color Coded Matte Finish Wingless Clamps Hygenic® Brinker Clamps BioSonic US200 UltraSonic Scaler PARAPOST FIBER WHITE ParaPost Fiber White Plus ORA SHIELD ParaPost System® Coltolux Comfort LED Curing Light CanalPro EDTA MM-EDTA CREAM PerFect TCS II Endo X-Move Bundle ENDO-ICE ENDO-ICE GREEN Wedjets Fiber Lux Plus Tenax Fiber Trans ParaPost Fiber Lux® ParaPost Taper Lux® Taper Lux Plus Tenax Fiber Trans Plus BIOSONIC ULTRASONIC SCALER SYSTEM DENTRONIX DDS 7000 DRY HEAT STERILIZER CanalPro Color Syringes Metal Wrench B Metal Wrench A Parapost Paraform including: Coreformer Refills, Sets & Kits Bending Tools CanalPro CL2 CanalPro NaOCI CanalPro NaOCI EXTRA Diatech Diamond Instruments Alpen Diamond Instruments Alpen Alpen Speedster Zr Plus DIATECH Z-Rex DIATECH Alpen Z-Rex CANALPRO SYRINGE STATION Dental Dam Forceps CanalPro CL

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only