Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004362235

FEI Number

3004362235

Entity Name

IVOCLAR VIVADENT, INC.

City/State/Country

Diezmo, Cabuyao City Laguna, PH

Establishment Address

#10 Ampere St., Light Industry & Science Park 1, Special Economic Processing Zone, Diezmo, Cabuyao City Laguna 4025, PH

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 e.max ZirCAD Prime PREFERENCE PhysioStar NFC Plus Bonartic II NFC Plus Condyloform II NFC Plus Cavifil Injector OptraSculpt Instruments OptraStick SR ORTHOLINGUAL DCL SR VIVODENT DCL SR Orthotyp DCL Candulor brand denture teeth Candulor Physioset TCR Candulor Bonartic TCR BlueLine SR ORTHOPLANE DCL 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 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2015-01-07
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2010-01-29
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2012-05-22
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2001-10-25
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2004-01-14
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2005-07-05
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2016-05-19
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2018-06-14

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
1316092	IVOCLAR VIVADENT, INC.	AMHERST, NY, US
3003310824	Ivoclar Vivadent Manufacturing GmbH	NATURNO (BZ) Bolzano, IT

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
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

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 3004362235. Last updated year: 2026. Please use registration number 3004362235 when referencing this establishment in official correspondence.