Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005974404

FEI Number

3005974404

Entity Name

Klema Dentalprodukte GMBH

City/State/Country

Meiningen Vorarlberg, AT

Establishment Address

Koblacherstrasse 3A, Meiningen Vorarlberg 6812, AT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GC America Inc. (Owner Number: 8030268)

Owner / Operator Contact Address

3737 W. 127th Street, Alsip, IL 60803, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K972594

PMA Number

N/A

All Registered Proprietary Names

MSCB-001 Initial Lustre Pastes NF Initial IQ Initial LiSi Initial PC Initial Initial TI Initial Spectrum Stains Initial Lustre Paste One Initial IQ SQIN Creation Creation CC Creation Magic Colour Creation ZI-CT, ZI-F Lisi PressVest Creation LS Initial One Initial Brush WILLI GELLER CREATION ZI PORCELAIN CREATION CP-ZI PORCELAIN GC Initial Zirconia Disk ST GC Initial Zirconia Disk HT GC Aadva Zr Disk GC Initial ZR Disk ML Elite WILLI GELLER CREATION PORCELAIN WILLI GELLER CREATION CP PORCELAIN WILLI GELLER CREATION II PORCELAIN Aadva Zr Coloring Liquid WILLI GELLER CREATION AND LF PORCELAIN METALPRIMER II

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2016-03-28
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2007-11-30
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2014-04-10
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2014-04-10
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2009-01-12
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2014-04-10
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2014-04-10
ELL	Teeth, Porcelain	Dental	Class 2	872.3920	2014-04-10
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2014-04-10
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2009-11-06
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2014-04-10
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-01-14

Official Correspondent

Futoshi Fusejima

US Agent Details

Futoshi Fusejima Business: GC America Inc. Email: futoshi.fusejima@gc.dental Phone: (708) 9263050

Related Public Records

Same Entity

GC America Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3027555943	GC Corporation Mishima Factory	Sunto-Gun Shizuoka, JP
3004146043	GC ASAHI CORPORATION	AICHI, JP
3001949270	WINNING APPLIANCE MANUFACTORY LIMITED	CHAI WAN HONG KONG Xinjiang, CN
3004046512	TSUEN LEE METALS & PLASTIC TOYS FACTORY	SHEN ZHEN CITY Guangdong, CN
9710611	STICK TECH LTD.	TURKU Pirkanmaa, FI

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22
K801093	Dentsply Intl.	PRISMA-BOND	1980-05-20
K061981	Apex Dental Materials, Inc.	SURPASS	2006-07-31
K110302	3M Espe AG	ADHESIVE EXL-759	2011-05-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Z-0021-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005974404. Last updated year: 2026. Please use registration number 3005974404 when referencing this establishment in official correspondence.