Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613375

FEI Number

3002806620

Entity Name

COLTENE/WHALEDENT AG

City/State/Country

ALTSTAETTEN Sankt Gallen, CH

Establishment Address

FELDWIESENSTRASSE 20, ALTSTAETTEN Sankt Gallen CH-9450, CH

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

K160800

PMA Number

N/A

All Registered 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 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 DUO TEMP A.R.T. Bond Coltosol F Diatech, SwissTEC, SwissBurs KENDA C.G.I. KENDA Zircovis KENDA Nobilis KENDA All Ceramic KENDA Diagum Disposable KENDA Prophy KENDA FG Series KENDA Amalgam KENDA Composite Microfill Disposable KENDA Composite Microfill Disposable KENDA Big Job KENDA Maximus KENDA Planus KENDA Prophy KENDA Dental Polishers Disposable KENDA C.G.I. Disposable KENDA G.P.S. Disposable KENDA Hybrid KENDA Hybrid KENDA Deluxe Disposable KENDA Unicus Disposable KENDA Nobilis KENDA Complete KENDA Unicus KENDA Precious Metals 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 KENDA Planus KENDA Amalgam KENDA Precious Metals Disposable KENDA Unicus KENDA Nobilis KENDA Deluxe KENDA Zircovis KENDA Dental Polishers KENDA Complete KENDA Diagum KENDA FG Series Disposable KENDA Composite Microfill Disposable KENDA Hybrid Disposable KENDA C.G.I. Disposable KENDA G.P.S. Disposable KENDA Nobilis Disposable KENDA Big Job Disposable KENDA Prophy KENDA C.G.I. KENDA Maximus KENDA Composite Microfill KENDA Unicus KENDA Hybrid KENDA Prophy KENDA All Ceramic Diatech, SwissTEC Disks BRILLIANT EverGlow Flow BRILLIANT Bulk Fill Flow Speedex Coltex Coltoflax President ParaPost ParaCore automix ParaCore DuoCem

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2014-03-03
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-09
ELW	Material, Impression	Dental	Class 2	872.3660	2007-11-08
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2016-07-22
ELW	Material, Impression	Dental	Class 2	872.3660	2007-11-08
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2018-09-27
ELW	Material, Impression	Dental	Class 2	872.3660	2007-11-09
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2016-07-22
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2007-11-09
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	2010-08-11
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-03-03
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2007-11-09
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-11-08
EHL	Point, Abrasive	Dental	Class 1	872.6010	2013-01-25
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-09
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-09
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2012-11-16
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2021-04-26
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2009-10-28
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2018-04-27
EMA	Cement, Dental	Dental	Class 2	872.3275	2009-09-16
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	2013-01-17
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2019-06-26
ELW	Material, Impression	Dental	Class 2	872.3660	2007-11-08
ELW	Material, Impression	Dental	Class 2	872.3660	2007-11-09
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-08
EMA	Cement, Dental	Dental	Class 2	872.3275	2016-12-09

Official Correspondent

No official correspondent registered.

US Agent Details

Tricia Cregger Business: Coltene/Whaledent Inc Email: tricia.cregger@coltene.com Phone: (330) 9168904

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

Registration Number	Establishment Name	Location
3012832388	DIATECH DENTAL INC	Mount Pleasant, SC, US
8030962	Micro-Mega SA	BESANCON Doubs, FR
2416455	COLTENE/WHALEDENT INC.	CUYAHOGA FALLS, OH, US
8043629	SCICAN LTD.	TORONTO Ontario, CA

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

Similar Registrations

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3010864832	3D DENTAL DESINGS AND DEVELOPMENT	Shaker Heights, OH, US
9616065	MANUFACTURERA DENTAL CONTINENTAL	ZAPOPAN Jalisco, MX
3004096429	E.M.S. ELECTRO MEDICAL SYSTEMS S.A.	NYON Vaud, CH
3007210751	DENTSCARE LTDA	Joinville Santa Catarina, BR
9681210	S & C POLYMER GMBH	ELMSHORN Schleswig-Holstein, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613375. Last updated year: 2026. Please use registration number 9613375 when referencing this establishment in official correspondence.