Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000625496

FEI Number

4838

Entity Name

VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG.

City/State/Country

BAD SACKINGEN Baden-Wurttemberg, DE

Establishment Address

SPITALGASSE 3, BAD SACKINGEN Baden-Wurttemberg D-79704, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG. (Owner Number: 9052908)

Owner / Operator Contact Address

Spitalgasse 3, --, BAD SACKINGEN, DE-BW D-79713, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K914476

PMA Number

N/A

All Registered Proprietary Names

Titanium VITA Lumex VITA VIONIC BOND Response Akzent LC VITA VIONIC VIGO YZ SHADE LIQUID, YZ EFFECT LIQUID VM7, VM 8, VM9, VM11, VM13, VM15 CAD Temp VITAdur Alpha Ceramic D VITA ENAMIC Polishing Set VITA SUPRINITY® Polishers n!ce Zirconia GT VITA YZ Multi Translucent VITA VIONIC WAX CAD Waxx Omega Omega 800 Omega 900 Celay Blanks Celay Optimizer VITAFol H In-Ceram Alumina VITA ENAMIC Blocks VITAdur-N VMLC Primer Vitablocs, Triluxe, Triluxe Forte VITA SUPRINITY VITA Ambria VITA VIONIC® DENT RESIN VM LC Flow Zeta LC Zeta CC Zeta HC Zeta HLC VM CC VM LC VITA YZ ST and VITA YZ XT VITA YZ ST Multicolor and VITA YZ XT Multicolor VITA VIONIC® BASE RESIN IMPACT Alumina Blanks Spinell Blanks Spinell Optimizer Alumina Optimizer In-Ceram Zirconia VITAchrom-L Interno Akzent, AL Coloring Liquid, YZ Coloring Liquid VITA Vionic Dent Disc Resin Powder Scan Spray VITAPAN, VITAPAN PLUS, VITAPAN EXCELL, VITAPAN CUSPIFORM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2007-11-28
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2021-03-25
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2021-03-25
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2007-11-28
EBD	Coating, Filling Material, Resin	Dental	Class 2	872.3310	2021-11-29
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2020-03-11
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2015-08-25
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2007-11-21
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2007-12-14
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2007-11-28
EHL	Point, Abrasive	Dental	Class 1	872.6010	2013-04-25
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2025-03-06
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2006-03-24
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2007-11-28
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2007-12-17
EFX	Protector, Silicate	Dental	Class 1	872.6670	2008-02-28
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2007-12-17
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2013-01-14
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2013-01-14
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2007-11-28
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2026-03-04
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2010-09-08
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2014-03-20
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2021-03-25
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	Class 2	872.3590	2025-07-23
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2016-01-23
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-12-20
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2018-08-13
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2025-07-23
ELL	Teeth, Porcelain	Dental	Class 2	872.3920	2007-12-17
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2007-11-28
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2025-07-23
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-07-23
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2013-03-01
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2007-11-19

Official Correspondent

No official correspondent registered.

US Agent Details

Lindsay Tilton Business: Vita North America Email: ltilton@vitanorthamerica.com Phone: (925) 6999091

Related Public Records

Same Entity

VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG.

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
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19
K093019	Enamelite, LLC	ENAMELITE ACRYSEAL SPRAY SEALANT	2009-12-22
K030585	Bisco, Inc.	SCULPTING RESIN	2003-04-28

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 1000625496. Last updated year: 2026. Please use registration number 1000625496 when referencing this establishment in official correspondence.