Data / Medical devices / Germany / Coltene/Whaledent GMBH & Co. KG

Coltene/Whaledent GMBH & Co. KG: FDA-registered device maker in LANGENAU Baden-Wurttemberg, Germany, 4 510(k) clearances

Name: Coltene/Whaledent GMBH & Co. KG FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Coltene/Whaledent GMBH & Co. KG is registered with the FDA (registration 8010629) in LANGENAU Baden-Wurttemberg, Germany. It lists 13 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 26, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8010629
FEI number: 3001180585
Address: Raiffeisenstrasse 30, LANGENAU Baden-Wurttemberg, Germany, 89129
Owner or operator: COLTENE Holding AG (9047609)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: September 27, 1983
Registered through: 2026
Brand names listed: Alpen Steel separating strips, CanalPro CalciSeal, CanalPro Color Syringes, CanalPro X-Move, HANEL Articulating paper, HANEL Foil Dispenser, HANEL OccluFoil+, HANEL Occlusion Foil and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter And Tip, Suction	JOL	2	Manufacturer	accessdata.fda.gov
Cord, Retraction	MVL	U	Manufacturer	accessdata.fda.gov
Cotton, Roll	EFN	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dam, Rubber	EIE	1	Contract manufacturer	accessdata.fda.gov
File, Pulp Canal, Endodontic	EKS	1	Manufacturer	accessdata.fda.gov
Gutta-Percha	EKM	1	Manufacturer	accessdata.fda.gov
Handpiece, Direct Drive, Ac-Powered	EKX	1	Exporter to the US	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Manufacturer	accessdata.fda.gov
Paper, Articulation	EFH	1	Manufacturer	accessdata.fda.gov
Point, Paper, Endodontic	EKN	1	Manufacturer	accessdata.fda.gov
Resin, Root Canal Filling	KIF	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Strip, Polishing Agent	EHM	1	Manufacturer	accessdata.fda.gov
Syringe, Periodontic, Endodontic, Irrigating	EIC	1	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 26, 2024	K232182	One-Fil	KIF	Substantially Equivalent	Mediclus Co., Ltd.	accessdata.fda.gov
May 10, 2021	K203320	Endo Motor	EKX	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.	accessdata.fda.gov
June 15, 2004	K041023	STAY-PUT IMPREGNATED	MVL	Substantially Equivalent	Coltene/Whaledent GmbH & Co. KG	accessdata.fda.gov
November 3, 2003	K032662	GUTTAFLOW	KIF	Substantially Equivalent	Coltene/Whaledent GmbH & Co. KG	accessdata.fda.gov

Compare with other makers

Updated January 26, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.