Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2416455

FEI Number

2416455

Entity Name

COLTENE/WHALEDENT INC.

City/State/Country

CUYAHOGA FALLS, OH, US

Establishment Address

235 Ascot Pkwy, CUYAHOGA FALLS, OH 44223, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Coltene/Whaledent AG (Owner Number: 9089944)

Owner / Operator Contact Address

Altstaetten, Feldwiesenstrasse 20, Altstaetten, CH-SG CH 9450, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 Jiffy HiShine Cups Jiffy HiShine Points Jiffy Cups Jiffy HiShine Disks Jiffy Disks Disposable KENDA Nobilis KENDA C.G.I. KENDA Amalgam KENDA Unicus KENDA Nobilis KENDA Zircovis KENDA FG Series Disposable KENDA Big Job Jiffy Points 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZM	Needle, Dental	Dental	Class 1	872.4730	2012-08-28
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	1996-03-01
EJL	Bur, Dental	Dental	Class 1	872.3240	2007-05-08
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	1996-09-30
EJE	Frame, Rubber Dam	Dental	Class 1	872.6300	2003-10-07
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2008-03-18
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2012-11-29
LQY	Locator, Root Apex	Unknown	Class U	N/A	2008-02-28
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2003-12-09
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2002-05-16
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2019-04-23
EIE	Dam, Rubber	Dental	Class 1	872.6300	2003-10-07
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2014-03-03
EIE	Dam, Rubber	Dental	Class 1	872.6300	2021-05-03
LQY	Locator, Root Apex	Unknown	Class U	N/A	2018-09-19
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2010-10-22
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2011-01-18
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2009-10-28
EBL	Pin, Retentive And Splinting, And Accessory Instruments	Dental	Class 1	872.3740	1996-09-30
KJJ	Cleanser, Root Canal	Unknown	Class U	N/A	2012-09-25
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	2010-08-11
ELR	Post, Root Canal	Dental	Class 1	872.3810	2008-03-03
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	1996-12-13
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2008-02-28
EEF	Clamp, Rubber Dam	Dental	Class 1	872.6300	2003-10-07
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2024-08-01
ELR	Post, Root Canal	Dental	Class 1	872.3810	2008-03-03
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2003-10-07
ELR	Post, Root Canal	Dental	Class 1	872.3810	2008-03-03
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2023-02-14
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	2018-09-19
EKZ	Unit, Electrosurgical, And Accessories, Dental	Dental	Class 2	872.4920	2008-02-29
EAT	Tester, Pulp	Dental	Class 2	872.1720	2024-03-08
EIE	Dam, Rubber	Dental	Class 1	872.6300	2008-02-28
ELR	Post, Root Canal	Dental	Class 1	872.3810	1996-09-30

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Coltene/Whaledent AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

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9613375	COLTENE/WHALEDENT AG	ALTSTAETTEN Sankt Gallen, CH

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Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2416455. Last updated year: 2026. Please use registration number 2416455 when referencing this establishment in official correspondence.