Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2244842

FEI Number

2244842

Entity Name

Ivoclar Vivadent Manufacturing, Inc

City/State/Country

Somerset, NJ, US

Establishment Address

500 MEMORIAL DR., Somerset, NJ 08873, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

IPS Ivocolor IPS Ivocolor Intro Kit IPS e.max Ceram Art Monobond Plus Adhese Universal Adhese 100 Adhese Universal kit VivaPen Adhese Universal Refill VivaPen Adhese Universal Test Pack VivaPen Aesthetic Wax Multilink Automix Multilink Automix Try-In 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 IPS e.max ZirCAD Prime Tetric 100 Universal Cervitec Plus 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 IPS e.max Press MT IPS e.max Press IPS e.max Press Multi AccuDent XD Impression Tray Centric Tray AccuDent XD Tray Adhesive IPS Empress CAD for Planmill IPS Empress CAD for PrograMill IPS Empress CAD for M-Center IPS EmpressCAD Tetric Evo-Line System Kit Tetric Evo-Line Tetric Prime Tetric Evo-Line Workshop Kit Tetric EvoCeram Tetric 100 Universal 2 Tetric Line Ivotion Bond Ivotion Base Ivotion Tetric EvoFlow Tetric 100 Flow Tetric 100 Flow 2 Telio Onlay Telio Inlay Heliobond Tetric 100 Bulk Flow Tetric PowerFlow Tetric PowerFill Tetric 100 Bulk Fill IPS e.max ZirCAD MT Multi blocks IPS e.max ZirCAD MT discs IPS e.max ZirCAD Prime Esthetic Multilink Hybrid Abutment Test Pack IPS Empress Direct Helioseal F Plus Cervitec F IPS e.max CAD Crystall IPS Style Ceram IPS Style Ceram One IPS Build-Up Liquid IPS Style Ceram Transpa 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2015-10-29
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2009-05-13
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2014-02-12
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2014-02-12
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2007-01-31
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2013-03-13
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2007-11-15
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2015-01-07
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-14
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2007-11-14
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2007-11-14
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2012-06-28
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	1990-04-16
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2007-11-14
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	1982-02-10
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2015-08-13
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2018-06-14
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-15
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2013-03-13
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2007-11-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2015-06-16
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2019-03-14
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2015-12-17
EMA	Cement, Dental	Dental	Class 2	872.3275	2013-08-22
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2009-04-30
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2019-07-30
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2020-02-12
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2011-04-27
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2016-05-24
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2007-11-14

Official Correspondent

Dana Glina

US Agent Details

No US Agent registered (Local establishment).

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
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 2244842. Last updated year: 2026. Please use registration number 2244842 when referencing this establishment in official correspondence.