Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004966444

FEI Number

3004966444

Entity Name

Ivoclar Vivadent GmbH

City/State/Country

Ellwangen Baden-Wurttemberg, DE

Establishment Address

Dr. Adolf-Schneider-Str.4, Ellwangen Baden-Wurttemberg D-73479, DE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

IVOCLAR VIVADENT (Owner Number: 8010208)

Owner / Operator Contact Address

175 Pineview Dr., Amherst, NY 14228, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SR Vivodent S PE SR Orthotyp S PE SR Vivodent S DCL SR Orthotyp S DCL SR Ortholingual S DCL PhysioSelect TCR BonSelect TCR Ivotion Dent IPS e.max Press Abutment Solutions for Nobel Biocare Cavifil Injector OptraSculpt Instruments OptraStick SR-IVOLEN TRAY MATERIAL SR-IVOLEN ProArt CAD Try-In IPS Empress Direct Effect SR Orthotyp Candulor brands SR Vivodent Preference Posterior SR Ivostar Preference Anterior SR Gnathostar SR Vivodent A-D SR Orthotyp A-D Monobond Etch & Prime IPS e.max ZirCAD MT Multi blocks IPS e.max ZirCAD MT discs IPS e.max ZirCAD Prime Esthetic IPS e.max CAD Crystall IPS Empress Direct Color IPS Empress Direct Opaque Chairside Workflow 3D Printing Adhese Universal Adhese 100 Adhese Universal kit VivaPen Adhese Universal Refill VivaPen Adhese Universal Test Pack VivaPen Tetric CAD Tetric CAD for PlanMill Tetric CAD for PrograMill Starter Kit Tetric CAD for CEREC Starter Kit Heliobond Adhese 2 Helioseal Clear SpeedCem Plus Multilink Speed SpeedCEM 100 Excite F DSC Excite F IPS e.max Press MT IPS e.max Press IPS e.max Press Multi IPS Empress Direct Ivotion Bond Ivotion Base Ivotion SR Link SR Orthotyp S SR Ortholingual S TelioCAD for M-Center TelioCAD for Milling Center Telio CAD for PlanMill Telio CAD for Cerec Telio CAD LT discs Telio CAD disc Telio CAD IPS e.max Press IPS e.max Press LT IPS e.max CAD Cryst Glaze Paste Fluo IPS e.max Press HO IPS e.max Press HT Cervitec F IPS e.max CAD Abutment Solutions- extra systems Multilink Hybrid Abutment Test Pack Tetric EvoFlow Tetric 100 Flow Tetric 100 Flow 2 Gnathometer- CAD Gnathometer-M Tetric PowerFill Tetric 100 Bulk Fill Heliomolar Heliomolar Flow Telio Onlay Telio Inlay OptraGloss Politip Fluor Protector S SR Ivocap High Impact OptraSculpt OptraSculpt Pad Heliomolar Trans Shades Bluephase G4 Bluephase G4 100 Bluephase EasyCure Multilink Automix Multilink Automix Try-In Silamat S6 Monobond Plus BasePlast Fibers AutoPlast Monomer BasePlast Monomer BasePlast Polymer Aesthetic Intensiv Color AutoPlast AutoPlast Polymer Triplex Cold Triplex Hot Aesthetic Cold Probase High Impact Hot XPLEX Probase Hot Probase Cold Aesthetic Hot Probase High Impact Cold Ivotion Base Print IvoBase Hybrid IvoBase High Impact PhysioStar NFC Plus Bonartic II NFC Plus Condyloform II NFC Plus Tetric 100 Bulk Flow Tetric PowerFlow IPS e.max Ceram Selection IPS e.max Ceram IPS Empress Staining IPS e.max Ceram Power IPS e.max CAD Crystall Glaze Spray IPS e.max CAD Crystall Stains IPS e.max CAD Crystall Shades IPS e.max CAD Crystall Glaze Paste IPS e.max Ceram Intro Kit IPS e.max Ceram Glaze Spray SR Ivocap IPS Ivocolor IPS Ivocolor Intro Kit IPS e.max Ceram Art ProArt CAD Splint OptraGate Small Assortment Blue & Pink OptraGate Junior Assortment Blue & Pink OptraGate for Scanning Assortment OptraGate Regular OptraGate Test Pack OptraGate Assortment OptraGate Small OptraGate Junior OptraGate 2 IPS e.max CAD for Planmill IPS e.max CAD MT IPS e.max CAD LT IPS e.max ZirCAD for Inlab IPS e.max CAD Impulse IPS e.max CAD HT IPS e.max CAD for InLab IPS e.max ZirCAD for PlanMill IPS e.max CAD CEREC IPS e.max CAD IPS e.max ZirCAD CAD/CAM CEREC Starter Kit CAD/CAM PlanMill Starter Kit SR Vivoperl Bonartic CT Physioset CT Virtual Dispenser Dispenser ZirCAD Cement Mixing Tips VivaPen Snap On Cannulas Vivadent Applicator Virtual Tips Variolink Application Tips Multilink Applicator Root Canal Tips Mixing Cannulas Intraoral Tips Mixing Tips Telio CAD Abutment Solutions Telio CAD A16 Abutment Solutions for CEREC/InLab Starter Kit Bluephase PowerCure Helioseal F Plus Universal Transferbow System (UTS) CAD Candulor Registration Set CRS-10 Bite Fork Set Bite Fork UNIVERSAL TRANSFERBOW UNIVERSAL TRANSFERBOW SYSTEM (UTS) SR Modelling Liquid SR Nexco Retention Flow Stains for Resin Teeth finisher SR Nexco SR Nexco Stains SR Nexco Paste SR Nexco Liner SR Nexco Opaquer Tetric Evo-Line System Kit Tetric Evo-Line Tetric Prime Tetric Evo-Line Workshop Kit Tetric EvoCeram Tetric 100 Universal 2 Tetric Line IPS e.max Zirconia IPS Style Ceram IPS Style Ceram One IPS Build-Up Liquid IPS Style Ceram Transpa OptraDam Plus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2016-05-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-04-09
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2001-10-25
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2005-07-07
EBD	Coating, Filling Material, Resin	Dental	Class 2	872.3310	2015-10-29
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2015-10-29
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2015-10-29
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2007-11-15
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2015-04-09
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2015-12-17
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2011-04-27
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2012-09-04
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2014-02-12
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2014-02-12
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2018-06-08
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2007-11-15
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2026-03-16
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2007-11-14
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2021-08-23
EMA	Cement, Dental	Dental	Class 2	872.3275	2009-06-04
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2010-03-11
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2012-06-28
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2009-04-30
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2015-08-13
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-29
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2007-11-29
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2014-01-28
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2010-03-16
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2007-11-15
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2020-02-12
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2019-09-09
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-09-09
EMA	Cement, Dental	Dental	Class 2	872.3275	2013-08-22
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-15
KZO	Ink, Arch Tracing	Dental	Class 1	872.3150	2017-09-28
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2019-03-14
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-14
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2013-03-13
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-28
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	2001-10-25
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2014-10-24
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2007-11-14
KXR	Applicator, Resin	Dental	Class 1	872.3140	2012-01-13
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-14
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2011-09-02
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2013-03-13
EFD	Amalgamator, Dental, Ac-Powered	Dental	Class 1	872.3100	2004-01-15
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2009-05-13
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2004-10-06
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2024-03-06
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2012-05-24
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2012-05-22
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2015-06-16
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2007-11-14
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2007-11-14
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2015-10-29
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2003-06-26
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2015-10-29
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2007-11-14
ELL	Teeth, Porcelain	Dental	Class 2	872.3920	2007-11-14
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2018-06-14
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2005-07-05
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2015-09-22
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2019-07-09
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2019-07-30
KCR	Facebow	Dental	Class 1	872.3220	2005-07-07
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2013-01-29
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	1982-02-10
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2026-03-16
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2016-05-24
EIE	Dam, Rubber	Dental	Class 1	872.6300	2001-11-13

Official Correspondent

Dana Glina

US Agent Details

Anderjeet Gulati Business: Ivoclar Vivadent Email: anderjeet.gulati@ivoclar.com Phone: (716) 2642046

Related Public Records

Same Entity

IVOCLAR VIVADENT

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3034244245	DSSM AG	Schaan, LI
3011511773	Candulor Dental GmbH	Rielasingen-Worblingen Baden-Wurttemberg, DE
3024046877	DSSM GmbH	Lindau Bavaria, DE
3004362235	IVOCLAR VIVADENT, INC.	Diezmo, Cabuyao City Laguna, PH
1316092	IVOCLAR VIVADENT, INC.	AMHERST, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
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-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
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.
Z-0017-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain

Similar Registrations

Registration Number	Establishment Name	Location
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3042623520	ZINGO DIGITAL DENTAL LAB LLC	Mount Prospect, IL, US
3010253209	ENTA B.V.	Bergen op Zoom Noord-Brabant, NL
3007740664	Shenzhen Jiahong Dental Technology Co., Ltd	Shenzhen Guangdong, CN
3002727993	GEBDI DENTAL PRODUCTS GMBH	Engen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004966444. Last updated year: 2026. Please use registration number 3004966444 when referencing this establishment in official correspondence.