Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010629

FEI Number

3001180585

Entity Name

COLTENE/WHALEDENT GMBH & CO. KG

City/State/Country

LANGENAU Baden-Wurttemberg, DE

Establishment Address

RAIFFEISENSTRASSE 30, LANGENAU Baden-Wurttemberg 89129, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

COLTENE Holding AG (Owner Number: 9047609)

Owner / Operator Contact Address

FELDWIESENSTRASSE 20, --, ALTSTAETTEN, CH-SG 9450, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Luna Gold ROEKO Solomat-N ROEKO Lunamat ROEKO Solomat-Click ROEKO Roll-o-mat ROEKO Luna ROEKO Cotton-roll ROEKO Parotisroll ROEKO Cotton Pellets ROEKO Parotimat REOKO Comprecap ROEKO Comprecap (anatomic) HySolate Flexi Dam ROEKO Gutta Flow® 2 Accessories (Mixing tips) Alpen Steel separating strips ROEKO Stay put non impregnated ROEKO Retracto CanalPro Color Syringes Hygenic Gutta Percha Points HyFlex Guttapercha Points MicroMega Guttapercha Points ROEKO Guttapercha Points ROEKO GuttaFlow ROEKO GuttaFlow 2 HyFlex Paper Points Hygenic(HYG) Paper Points (PP), HYG Absorbent PP, Hygenic Spectra Points Absorbent PP, HYG Steri-I-Cell PP MicroMega Paper Points ROEKO Paper Points

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFN	Cotton, Roll	Dental	Class 1	872.6050	1992-12-03
EIE	Dam, Rubber	Dental	Class 1	872.6300	1996-10-16
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2005-10-20
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2025-09-15
MVL	Cord, Retraction	Unknown	Class U	N/A	2008-03-07
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2019-01-21
EKM	Gutta-Percha	Dental	Class 1	872.3850	1983-09-27
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2008-12-19
EKM	Gutta-Percha	Dental	Class 1	872.3850	2008-12-19
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	1992-12-03

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 Holding AG

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02

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2029234	PLASDENT CORP.	POMONA, CA, US
3005621808	ANJI HONGDE MEDICAL PRODUCTS CO., LTD.	HUZHOU Zhejiang, CN
3016826509	TAIZHOU RICH MEDICAL PRODUCTS CO., LTD.	TAIZHOU Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010629. Last updated year: 2026. Please use registration number 8010629 when referencing this establishment in official correspondence.