Not currently registered with FDA under this name

Ivoclar North America, Inc.

Amherst, NY, United States. Named as applicant on 131 dental 510(k) clearances between 1989 and 2001. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 1311989–2001
Markets registered in: 21 registrations outside the US
Establishments: 0—

510(k) clearances per year, 1980–2026

Registered in 2 markets

Where regulators' registries name Ivoclar North America, Inc. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Ivoclar North America, Inc.	131 clearances	1989–2001	Below
Taiwan	TFDA	Manufacturer	IVOCLAR NORTH AMERICA, INC.	1	2007–2007	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

510(k) clearances

Clearances on which FDA names Ivoclar North America, Inc. as the applicant.

Decided	510(k)	Device	Device type
27 Aug 2001	K012174	ERIS LAYERING MATERIALS	EIH Porcelain Powder
16 Aug 2001	K011491	HELIOSEAL CLEAR CHROMA	EBC Pit and Fissure Sealant and Conditioner
5 Jul 2001	K011492	IN TEN-S	EBF Resin Tooth Shade Material
27 Jun 2001	K011490	MODIFICATION TO EXCITE	KLE Resin Tooth Bonding Agent
2 May 2001	K011023	D.SIGN 96	EJT Gold-Based Noble Metal Alloy
2 May 2001	K011022	BIOUNIVERSAL PDF	EJT Gold-Based Noble Metal Alloy
6 Mar 2001	K010381	D.SIGN 30	EJH Base Metal Alloy
28 Feb 2001	K010250	TETRIC CERAM HB	EBF Resin Tooth Shade Material
6 Feb 2001	K003293	EXCITE DSC	KLE Resin Tooth Bonding Agent
26 Jan 2001	K003407	SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER)	EMA Dental Cement
22 Dec 2000	K003635	DW 276 #3	EJT Gold-Based Noble Metal Alloy
21 Dec 2000	K003634	DW 272 #1	EJT Gold-Based Noble Metal Alloy
20 Dec 2000	K003633	DW 277 #4	EJT Gold-Based Noble Metal Alloy
20 Dec 2000	K003632	DW 273 #1	EJS Alloy Other Noble Metal
4 Dec 2000	K003377	FERMIT N PLUS	EBG Resin Temporary Crown and Bridge
4 Dec 2000	K003374	FERMIT PLUS	EBG Resin Temporary Crown and Bridge
28 Nov 2000	K003373	PROCAD ADD-ON	EIH Porcelain Powder
2 Nov 2000	K002872	R&D PROJECT DW271#11A	EJT Gold-Based Noble Metal Alloy
5 Jul 2000	K001469	R&D PROJECT DW269#25	EJS Alloy Other Noble Metal
13 Dec 1999	K993783	TETRIC FLOW	EBF Resin Tooth Shade Material
6 Apr 1999	K990817	IPS D.SIGN PORCELAIN	EIH Porcelain Powder
19 Mar 1999	K990534	EXCITE	KLE Resin Tooth Bonding Agent
4 Mar 1999	K990315	MONOPAQUE	EBF Resin Tooth Shade Material
1 Mar 1999	K990235	D-SIGN VI (R&D PROJECT DW266#9)	EJH Base Metal Alloy
1 Mar 1999	K990182	D-SIGN V (R&D PROJECT DW267#17)	EJH Base Metal Alloy
12 Feb 1999	K990078	D-SIGN IV (R&D PROJECT DW265#37)	EJS Alloy Other Noble Metal
12 Feb 1999	K990077	D-SIGN III (R&D PROJECT DW264#7)	EJS Alloy Other Noble Metal
19 Jan 1999	K984451	D-SIGN I (R&D PROJECT DW263 #24)	EJS Alloy Other Noble Metal
8 Sep 1998	K982616	IPS EMPRESS 2	EIH Porcelain Powder
2 Jul 1998	K981335	ARISTON PHC LINER	EMA Dental Cement
30 Apr 1998	K980922	PROTEC CEM.	EMA Dental Cement
30 Jan 1998	K974577	COMPOGLASS FLOW	EBF Resin Tooth Shade Material
21 Nov 1997	K973397	SYNTAC SPRINT	EMA Dental Cement
30 Oct 1997	K972648	SONICSYS INLAY	EIH Porcelain Powder
17 Sep 1997	K972875	COSMOPOST	ELR Root Canal Post
17 Sep 1997	K972827	IPS EMPRESS COSMO INGOT	EIH Porcelain Powder
3 Jun 1997	K971513	COMPOGLASS F	EBF Resin Tooth Shade Material
29 May 1997	K971372	VARIOLINK II	EBF Resin Tooth Shade Material
30 Apr 1997	K970963	TARGIS ALLOY #7	EJT Gold-Based Noble Metal Alloy
22 Jan 1997	K964285	TETRIC CERAM	EBF Resin Tooth Shade Material
17 Jan 1997	K964772	AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS)	EJT Gold-Based Noble Metal Alloy
25 Sep 1996	K962878	TARGIS SYSTEM	EBF Resin Tooth Shade Material
6 Aug 1996	K962456	SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH	ELM Teeth Plastic Denture
26 Jun 1996	K962297	VIVAGLASS CEM	EMA Dental Cement
26 Jun 1996	K961910	VIVAGLASS FIL	EMA Dental Cement
15 Nov 1995	K954837	DW260 19	EJT Gold-Based Noble Metal Alloy
25 May 1995	K951836	COMPOLGLASS COMPOGLASS SCA	EBF Resin Tooth Shade Material
18 Apr 1995	K951298	MAXIGOLD KF	EJT Gold-Based Noble Metal Alloy
18 Apr 1995	K951297	HARMONY LINE KF	EJT Gold-Based Noble Metal Alloy
23 Mar 1995	K950517	HARMONY LINE PF	EJT Gold-Based Noble Metal Alloy
7 Mar 1995	K946032	FLUOR PROTECTOR	LBH Cavity Varnish
17 Feb 1995	K950428	VIVAGLASS BASE	EMA Dental Cement
10 Feb 1995	K950060	PROVILINK	EMA Dental Cement
22 Jul 1994	K930835	VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A	ELL Porcelain Teeth
7 Mar 1994	K926177	DW246 #43	EJT Gold-Based Noble Metal Alloy
10 Dec 1993	K934978	FERMIT N LIGHT-CURING TEMPORARY FILLING MATERIAL	EBG Resin Temporary Crown and Bridge
17 Nov 1993	K934611	STO2P	EBF Resin Tooth Shade Material
7 Oct 1993	K930128	SR SPECTRASIT, SR CHROMASIT	EBF Resin Tooth Shade Material
29 Sep 1993	K933186	DW 248 #46	EJT Gold-Based Noble Metal Alloy
29 Sep 1993	K933083	DW247 #2	EJT Gold-Based Noble Metal Alloy
15 Sep 1993	K932078	HELIOSEAL F	EBC Pit and Fissure Sealant and Conditioner
22 Jul 1993	K931502	VIVAGLASS LINER	EJK Calcium Hydroxide Cavity Liner
22 Jul 1993	K931309	VARIOLINK	EBF Resin Tooth Shade Material
22 Jun 1993	K931365	DW207 #28G, DW207 #35F, DW207 #39LC	EJT Gold-Based Noble Metal Alloy
23 Apr 1993	K926556	VIVALUX	EBF Resin Tooth Shade Material
27 Oct 1992	K923926	IPS CERAMIC ETCHING GEL	ELL Porcelain Teeth
6 Oct 1992	K923974	SILIMAT PLUS	EFD Ac-Powered Dental Amalgamator
15 Jul 1992	K922569	TETRIC LIGHT-CURING COMPOSITE	EBF Resin Tooth Shade Material
21 Apr 1992	K920613	DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL	EJS Alloy Other Noble Metal
26 Mar 1992	K920244	DW240 #73C ALLOY FOR PORCELAIN FUSED TO METAL	EJT Gold-Based Noble Metal Alloy
2 Mar 1992	K920561	DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET.	EJH Base Metal Alloy
2 Mar 1992	K910069	SR-ISOSIT SPECTRA LINK SYSTEM	KLE Resin Tooth Bonding Agent
25 Feb 1992	K915626	EZ GOLD	EJT Gold-Based Noble Metal Alloy
31 Jan 1992	K915377	SR-IVOCAP PLUS	EBI Rebasing Repairing Relining Denture Resin
16 Dec 1991	K913980	HELIOLUX	EBZ Ultraviolet Activator for Polymerization
25 Oct 1991	K913372	IPS EMPRESS	EIH Porcelain Powder
17 Oct 1991	K913655	PROBASE HOT AND PROBASE COLD	EBI Rebasing Repairing Relining Denture Resin
2 Oct 1991	K913069	DW238 #228-04B	EJS Alloy Other Noble Metal
2 Oct 1991	K913068	DW238 #228-34A	EJS Alloy Other Noble Metal
13 Sep 1991	K913070	X-L (DW228-14A) AND X-LX (DW228-24A)	EJS Alloy Other Noble Metal
17 Apr 1991	K904876	DW237	EJS Alloy Other Noble Metal
29 Mar 1991	K905204	DW 236	EJJ Amalgam Alloy
15 Mar 1991	K910068	SPECTRAMAT	EBZ Ultraviolet Activator for Polymerization
26 Feb 1991	K905329	WILL-CERAM W	EJT Gold-Based Noble Metal Alloy
26 Feb 1991	K905327	MAXIGOLD	EJT Gold-Based Noble Metal Alloy
26 Feb 1991	K905321	PLATINUM FOIL, VARIOUS SIZES	EIH Porcelain Powder
26 Feb 1991	K905320	WLW	EJT Gold-Based Noble Metal Alloy
17 Jan 1991	K905328	WILL-CERAM BRUSHES, SUPER BRUSH KIT	EIH Porcelain Powder
16 Jan 1991	K905322	MIDIGOLD 50	EJT Gold-Based Noble Metal Alloy
15 Jan 1991	K905319	VARIOUS	EJT Gold-Based Noble Metal Alloy
24 Dec 1990	K905330	HARMONY LINE ALLOYS	EJT Gold-Based Noble Metal Alloy
24 Dec 1990	K905326	MINIGOLD	EJT Gold-Based Noble Metal Alloy
24 Dec 1990	K905324	WILL-CERAM W-1	EJT Gold-Based Noble Metal Alloy
24 Dec 1990	K905323	WILL-CERAM Y AND WILL -CERAM Y-1	EJT Gold-Based Noble Metal Alloy
21 Dec 1990	K905325	X-L AND X-LX	EJT Gold-Based Noble Metal Alloy
17 Dec 1990	K905221	SPECIAL BOND II	EBF Resin Tooth Shade Material
17 Dec 1990	K905220	MONOBOND S	EBF Resin Tooth Shade Material
17 Dec 1990	K905205	DW 235	EJJ Amalgam Alloy
22 Oct 1990	K901260	CORADENT	EBF Resin Tooth Shade Material
9 Oct 1990	K903587	HELIOLINK TRY-IN PASTES	EBF Resin Tooth Shade Material
13 Jul 1990	K902052	AHYDRON DENTAL CLEANING AGENT	EMA Dental Cement
13 Jul 1990	K901908	HELIOLUX VISIBLE CURING LIGHT	EBZ Ultraviolet Activator for Polymerization
28 Jun 1990	K902376	DW231 DENTAL ALLOY	EJS Alloy Other Noble Metal
28 Jun 1990	K901917	DUAL CEMENT	EBF Resin Tooth Shade Material
28 Jun 1990	K901914	HELIO PROGRESS (DENTAL COMPOSITE)	EBF Resin Tooth Shade Material
27 Jun 1990	K901915	DENTIN PROTECTOR	LBH Cavity Varnish
26 Jun 1990	K901918	HELIOTINT	EBF Resin Tooth Shade Material
26 Jun 1990	K901913	SYNTAC (DENTIN BONDING AGENT)	KLE Resin Tooth Bonding Agent
26 Jun 1990	K901910	HELIO LINK (RESIN CEMENT)	EBF Resin Tooth Shade Material
26 Jun 1990	K901261	PV-CERAMIC, CERAMINIQUE	EIH Porcelain Powder
22 Jun 1990	K901919	CONTACT MOLAR BANDS AND CONTOUR STRIPS	DZN Dental Hand Instruments
22 Jun 1990	K901916	SPECIAL BOND	EBF Resin Tooth Shade Material
22 Jun 1990	K901909	SILAMAT (AMALGAMATOR)	EFD Ac-Powered Dental Amalgamator
1 Jun 1990	K901911	VIVAALLOY HR (AMALGAM)	EJJ Amalgam Alloy
29 May 1990	K901098	SPARTAN PLUS	EJT Gold-Based Noble Metal Alloy
25 May 1990	K896469	EOS INLAY MATERIAL	EBF Resin Tooth Shade Material
15 May 1990	K901396	CONCEPT INLAY/ONLAY	EBF Resin Tooth Shade Material
7 May 1990	K896530	FERMIT TEMPORARY MATERIAL	EBF Resin Tooth Shade Material
30 Apr 1990	K896468	EOS BLUEPHASE-P AND REDPHASE-P IMPRESSION MATERIAL	ELW Impression Material
27 Apr 1990	K901256	AMALCAP PLUS	EJJ Amalgam Alloy
25 Apr 1990	K901257	WIRONTOM CLASP WIRE	EJW Wire Clasp
25 Apr 1990	K901099	PROTOCOL (ALLOY)	EJS Alloy Other Noble Metal
25 Apr 1990	K901097	FILLOCK REAMER	DZA Intraoral Dental Drill
25 Apr 1990	K901024	STAINLESS STEEL DENTAL WIRES AND CLASPS	EJF Orthodontic Metal Bracket
16 Apr 1990	K896139	SR-IVOSEAL	EBI Rebasing Repairing Relining Denture Resin
16 Apr 1990	K896130	SR-IVOCAP	EBI Rebasing Repairing Relining Denture Resin
5 Mar 1990	K896928	FILPOST	ELR Root Canal Post
9 Feb 1990	K896470	EOS IMPRESSION TRAYS	EHY Preformed Impression Tray
16 Jan 1990	K896529	BASIC CALCIUM HYDROXIDE LINER	EJK Calcium Hydroxide Cavity Liner
10 Jan 1990	K896132	ENAMEL PREP ENAMEL ETCHANT (EMAIL-PREPARATOR GS)	EBF Resin Tooth Shade Material
4 Dec 1989	K896131	GNATHOMAT ARTICULATOR	EJP Articulators

Some of these clearances are listed with FDA today by another company: Ivoclar Vivadent, AG (12), Pan-Am Dental, Inc. (5).

Sources

FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.