Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1316092

FEI Number

1316092

Entity Name

IVOCLAR VIVADENT, INC.

City/State/Country

AMHERST, NY, US

Establishment Address

175 PINEVIEW DR., AMHERST, NY 14228, US

Establishment Type(s)

Manufacture Medical 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

Virtual CADbite ZirCAD Cement Spartan Solder Spartan Ceramic Solder d.SIGN 30 Colado NC Valiant PhD AccuDent XD Tray Material AccuDent XD Syringe Material Capricorn 15 Universal Solder 1015 W Super Solder Ceramic Solder Elektra Evolution Lite Solarcast 20 W-3 d.SIGN 91 Laser C&B White d.SIGN 53 IS-64 Aquarius Magenta d.SIGN 59 Laser C&B Yellow Aquarius Ceramic Solder Special High Fusing White Ceramic Solder Harmony X-Hard d.SIGN 67 W-2 Lodestar Universal Solder PKF Harmony 2 Rim Former New Bite Gauge Bite Plane 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 AccuDent XD Impression Tray Centric Tray AccuDent XD Tray Adhesive Aesthetic Wax Virtual XL-X HIgh Fusing Yellow Ceramic Solder Academy Gold XH Callisto Implant 33 Laser Ceramic Yellow Pdf Golden Ceramic Solder Harmony Medium Harmony Hard Brite Gold Maxigold KF Academy Gold Laser Ceramic Yellow Y .585 Fine Gold Solder Low Fusing White Gold Solder W W-1 d.SIGN 98 W-5 d.SIGN 96 HGPKF 1030 Y Solder .615 Fine Gold Solder X-L Y-1 Laser Ceramic White High Fusing White Ceramic Solder Midigold 50 Maxigold Minigold Aquarius Hard Callisto 75 Pd HGPKF 1015 Y Solder Harmony C & B 55 Spartan Plus .650 Fine Gold Solder Callisto CPG

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELW	Material, Impression	Dental	Class 2	872.3660	2010-11-23
EMA	Cement, Dental	Dental	Class 2	872.3275	2021-03-03
ELW	Material, Impression	Dental	Class 2	872.3660	2013-01-04
EJH	Alloy, Metal, Base	Dental	Class 2	872.3710	2006-10-20
EJJ	Alloy, Amalgam	Dental	Class 2	872.3070	2007-11-14
ELW	Material, Impression	Dental	Class 2	872.3660	2015-04-09
EJS	Alloy, Other Noble Metal	Dental	Class 2	872.3060	2001-10-25
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2019-02-25
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2005-07-05
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	1990-04-16
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2007-01-31
ELW	Material, Impression	Dental	Class 2	872.3660	2007-11-14
ELW	Material, Impression	Dental	Class 2	872.3660	2021-03-26
EJT	Alloy, Gold-Based Noble Metal	Dental	Class 2	872.3060	2001-10-30

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
3003310824	Ivoclar Vivadent Manufacturing GmbH	NATURNO (BZ) Bolzano, IT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K952614	Dentsply Intl.	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	1996-08-13
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31
K062064	Southern Dental Industries, Inc.	RIVA BOND LC	2006-11-09

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
Z-0022-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain
Z-0023-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring dental porcelain
Z-0024-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain
Z-0025-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain
Z-0026-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain
Z-0027-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring dental porcelain
Z-0028-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain
Z-0029-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain
Z-0030-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring dental porcelain
Z-0031-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain
Z-0032-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring dental porcelain
Z-0033-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain
Z-0034-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain
Z-0035-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain
Z-0036-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain
Z-0037-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain

Similar Registrations

Registration Number	Establishment Name	Location
3030268763	OWL DENTAL	San Leandro, CA, US
8021038	VANNINI DENTAL INDUSTRY SRL	GRASSINA(FI) Firenze, IT
2018957	DEN-MAT HOLDINGS, LLC	Lompoc, CA, US
3005558160	MAXILL, INC.	ST. THOMAS Ontario, CA
9611385	Solventum Germany GmbH	SEEFELD Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1316092. Last updated year: 2026. Please use registration number 1316092 when referencing this establishment in official correspondence.