Prosthetic devices · 21 CFR 872 Subpart D

Gold-Based Noble Metal Alloy

FDA device type “Alloy, Gold-Based Noble Metal”.

FDA codeEJTClass221 CFR872.3060Pathway510(k) exemptCategoryDental alloys

Companies listing it: 4027 makers
Brands and models: 860
510(k) clearances: 6270 in five years
FDA name: Alloy, Gold-Based Noble Metal

510(k) clearances per year, 1976–2026

Companies that list EJT

40 companies currently list this device type with FDA.

Company	Country	Role	Brands and models listed	Clearances	Latest
Dentsply Sirona, Inc.	United States	Maker	Option	148	2026
Ivoclar Vivadent, AG	United States	Maker	Academy Gold · Academy Gold XH · Aquarius Hard · Brite Gold · +32	94	2026
The Argen Corporation	United States	Maker	ALBORO HF · ALBORO LF · ALLOY FOR SINTERKOR · ALLROUND 4 · +728	11	2024
Aalba Dent, Inc.	United States	Maker	AALBA GOLD SOLDER · VERA PD SOLDER	27	2004
Sterngold	United States	Maker	Apollo · Criterion · Galaxy · Pegasus · +3	24	2017
Jensen Industries, Inc.	United States	Maker	Aztec · Classic IV · CPS Solder · Endurance · +33	17	2019
Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO	Germany	Maker	BEGOCER G · Bio PontoStar XL · PontoLloyd P	4	2013
Cendres+Metaux SA	Switzerland	Maker	—	2	2020
Qinhuangdao Audental Metal Technology Co., Ltd.	China	Maker	Audental 40A;Audental A52;Audental A6;Audental A62;Audental A83;Audental A77;Audental A75; · Audental 75+;Audental 65;Audental 62;Audental 54;Audental 52;Audental 52+;Audental 45; · Audental 90;Audental 86;Audental 74 ;Audental 50; Audental 03; Audental 04;Audental 22; Audental 40; · Audental 98;Audental 89;Audental 86+; Audental 87;Audental 86A;Audental 84;Audental 76;Audental 75; · +5	1	2020
Aurident, Inc.	United States	Maker	Aurident Alloys	1	2004
one day dental partner	South Korea	Maker	kage Alloy, gold-based noble metal	—	—
Digital Dental Depot Limited	Hong Kong SAR China	Maker	Alloy, gold-based noble metal · EJT / Alloy, gold-based noble metal	—	—
Shenzhen Sunmc Dental Technology Co., Ltd.	China	Maker	Alloy, gold-based noble metal	—	—
Fseven Dental Technology Zhuhai Co.,ltd	China	Maker	ALLOR,GOLD-BASED NOBLE METAL	—	—
Digital Dental Depot	China	Maker	Alloy, Gold Based Nobel Metal	—	—
Smilden Biotechnology CO., Ltd.	Taiwan	Maker	Alloy, gold-based noble metal	—	—
Shenzhen Jiahong Dental Technology Co., Ltd	China	Maker	EJT	—	—
Shenzhen HLD Dental&Technology Co.,Ltd	China	Maker	Argen	—	—
Worldlabusa	United States	Maker	Noble Alloy	—	—
Crown Trading (HK) Co., Limited	China	Maker	Alloy, Gold-Based Noble Metal	—	—
Shenzhen Times Dental Lab	China	Maker	Times Dental Custom Restorations	—	—
VIVI Dental Laboratory	China	Maker	Alloy, Gold-Based Noble Metal	—	—
Forbes Dental Prosthetics Inc.	Philippines	Maker	FORBES DENTAL	—	—
Smart Dental Cad Solutions Limited	China	Maker	Restoration, Noble Metal	—	—
Strategy Milling, LLC	United States	Maker	SM20, SM55 and PXN, noble and high noble alloys	—	—
Ocean Ceramics	Canada	Maker	Gold Crown	—	—
Shen FU Arts Lab	China	Maker	—	—	—
Purple Dental Tech	United States	Repacker / relabeler	Exquisite Dental Tech · Purple Dental Lab	—	—
Pan-Am Dental, Inc.	United States	Contract manufacturer	Alloy, gold-based noble metal · ALLOY, OTHER NOBLE METAL	—	—
DigiSmiles Lab	United States	Repacker / relabeler	Alloy, Gold-based Noble Metal	—	—
Primotec LLC	United States	Repacker / relabeler	AGC	—	—
Mountain Dental Lab Service Inc	United States	Repacker / relabeler	SHEN FU ARTS LAB	—	—
Olson Dental Laboratory, Inc.	United States	Repacker / relabeler	Alloy, Gold based noble metal	—	—
Showcase Dental Lab LLC	United States	Contract manufacturer	Alloy	—	—
Arvit Dental Laboratory Inc.	United States	Repacker / relabeler	GOLD-BASED NOBLE METAL	—	—
Damore Dental Lab LLC	United States	Repacker / relabeler	Dental appliance	—	—
Global Dental Technologies, Inc.	United States	Repacker / relabeler	ARTIFICIAL TEETH · BIO HERADOR N	—	—
Onestopdentalstudio Inc	United States	Repacker / relabeler	ALLOY, GOLD-BASED NOBLE METAL	—	—
Premiere 1 Dental Laboratory, LLC	United States	Repacker / relabeler	Alloy, Gold, Base Metal	—	—
A.D.L. Dental Lab	United States	Repacker / relabeler	—	—	—

510(k) clearances

Decided	510(k)	Device	Applicant
14 Oct 2005	K052463	PROMETAL HN86	Prometal Technologies
2 Aug 2004	K041378	BIO 60	Kodent, Inc.
27 May 2004	K040672	PORTA REFLEX	Wieland Dental + Technik GmbH & Co. KG
20 May 2004	K040524	PORTA SOLDER 1090 W	Wieland Dental + Technik GmbH & Co. KG
3 Mar 2004	K040043	NDX-40 ALLOY	Heraeus Kulzer, LLC
1 Mar 2004	K034049	HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM	Heraeus Kulzer, LLC
15 Jan 2004	K033279	GOLD DENTAL CASTING ALLOYS	Bego U.S.A.
13 Nov 2003	K033446	APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82	We Dong Myung Dental Industrial Co., Ltd.
12 Nov 2003	K033435	E-SARANG 86, DM78, DM55	We Dong Myung Dental Industrial Co., Ltd.
1 Oct 2003	K032320	APPOLLO 3 ALLOY	Dentsply International, Inc.
30 Sep 2003	K032321	CERA F ALLOY	Dentsply International, Inc.
30 Sep 2003	K032319	CERA R PLUS ALLOY	Dentsply International, Inc.
30 Sep 2003	K032318	MINERVA 58 ALLOY	Dentsply International, Inc.
30 Sep 2003	K032317	ORION GX ALLOY	Dentsply Intl., Inc.
30 Sep 2003	K032316	ORION E ALLOY	Dentsply Intl., Inc.
26 Sep 2003	K032851	ULTRACROWN 75 ALLOY	Dentsply International, Inc.
26 Sep 2003	K032715	DW 296 #15 SOLDER	Ivoclar Vivadent, AG
17 Sep 2003	K032267	R&D DESIGNATION AP-052-5	Jensen Industries, Inc.
4 Sep 2003	K032493	ALEXANDER	Ivoclar Vivadent, AG
25 Aug 2003	K032106	STARBOND DENTAL BONDING ALLOYS	Star Refining Precious Metals South Africa
25 Jun 2003	K031010	MIRACLE 98	Sb Lucius, Inc.
12 Jun 2003	K031264	PORTA PRESSOVER	Wieland Dental + Technik GmbH & Co. KG
30 May 2003	K031543	STARCAST DENTAL ALLOYS	Star Refining Precious Metals South Africa
15 Apr 2003	K030436	BIO UNIVERSAL	Ivoclar Vivadent, AG
15 Apr 2003	K030435	BIOUNIVERSAL PKF	Ivoclar Vivadent, AG
26 Mar 2003	K030312	PORTA IMPLANT	Wieland Dental + Technik GmbH & Co. KG
10 Mar 2003	K024143	AIGIS-FINE	Sb Lucius, Inc.
10 Mar 2003	K024142	AIGIS-SUPER	Sb Lucius, Inc.
10 Mar 2003	K024136	AIGIS-SOFT	Sb Lucius, Inc.
10 Mar 2003	K024135	AIGIS-PLUS	Sb Lucius, Inc.
7 Mar 2003	K024145	AIGIS-XO	Sb Lucius, Inc.
7 Mar 2003	K024144	AIGIS-PT	Sb Lucius, Inc.
7 Mar 2003	K024139	AIGIS-INLAY	Sb Lucius, Inc.
6 Mar 2003	K024141	NEO 76	Sb Lucius, Inc.
6 Mar 2003	K024140	AIGIS-A	Sb Lucius, Inc.
29 Jan 2003	K030206	APEX 90	We Dong Myung Dental Industrial Co., Ltd.
24 Jan 2003	K023831	UCP DENTAL MATERIAL	Precious Chemicals U.S.A., Inc.
21 Jan 2003	K023790	UCC DENTAL MATERIAL	Precious Chemicals U.S.A., Inc.
18 Dec 2002	K023501	GOLD CORE 35	Pentron Laboratory Technologies
11 Dec 2002	K023395	PORTADUR P2	Wieland Dental + Technik GmbH & Co. KG
10 Dec 2002	K023391	BIOPORTA G	Wieland Dental + Technik GmbH & Co. KG
6 Dec 2002	K023392	AGC SPECIAL ALLOY	Wieland Dental + Technik GmbH & Co. KG
6 Dec 2002	K023389	PORTA GEO TI	Wieland Dental + Technik GmbH & Co. KG
5 Nov 2002	K023197	CERANUM 82	Sb Lucius, Inc.
4 Nov 2002	K023200	CERANUM 76	Sb Lucius, Inc.
4 Nov 2002	K023199	CERANUM 50	Sb Lucius, Inc.
1 Nov 2002	K023198	CERANUM 90	Sb Lucius, Inc.
1 Nov 2002	K023196	LUCIUS 76	Sb Lucius, Inc.
31 Oct 2002	K022663	KERADEC	Wieland Dental + Technik GmbH & Co. KG
18 Oct 2002	K022969	UNIVERSAL CERAMIC SOLDER	Ivoclar Vivadent, AG
9 Oct 2002	K022811	W-5	Ivoclar Vivadent, AG
18 Sep 2002	K022470	PORTA SOLDER 1080 W	Wieland Dental + Technik GmbH & Co. KG
18 Sep 2002	K022462	BIOPORTA SOLDER 1020	Wieland Dental + Technik GmbH & Co. KG
17 Sep 2002	K022468	PORTA OPTIMUM SOLDER 900	Wieland Dental + Technik GmbH & Co. KG
17 Sep 2002	K022467	PORTA IP SOLDER V-2	Wieland Dental + Technik GmbH & Co. KG
17 Sep 2002	K022457	PORTA OPTIMUM SOLDER 710	Wieland Dental + Technik GmbH & Co. KG
17 Sep 2002	K022456	PORTA IP SOLDER V-1	Wieland Dental + Technik GmbH & Co. KG
12 Sep 2002	K022459	AUROPAL SOLDER M-1	Wieland Dental + Technik GmbH & Co. KG
12 Sep 2002	K022454	PORTA OP SOLDER W-2	Wieland Dental + Technik GmbH & Co. KG
11 Sep 2002	K022452	PORTA OP SOLDER M-1	Wieland Dental + Technik GmbH & Co. KG
11 Sep 2002	K022451	AUROPAL SOLDER W-2	Wieland Dental + Technik GmbH & Co. KG
3 Sep 2002	K021948	LUCIUS 62	Lucius Metals Com.
29 Aug 2002	K022206	JENSEN GOLD FOIL	Jensen Industries, Inc.
26 Aug 2002	K021947	CERANUM 87	Lucius Metals Com.
25 Jul 2002	K021926	AUROPAL 60	Wieland Dental + Technik GmbH & Co. KG
25 Jul 2002	K021892	BRIGHT GOLD	Ivoclar Vivadent, AG
26 Jun 2002	K021741	CRITERTION, MODEL #1067511	Sterngold
26 Jun 2002	K021733	AUTOPAL 50	Wieland Dental + Technik GmbH & Co. KG
16 May 2002	K021242	PORTALLOY 54	Wieland Dental + Technik GmbH & Co. KG
24 Apr 2002	K020347	AGC SPEZIALLEGIERUNG	Wieland Edelmetalle GmbH & Co.
4 Apr 2002	K020949	APOLLO, MODEL 1124525	Sterngold
13 Mar 2002	K020190	PORTADUR P 4	Wieland Dental + Technik GmbH & Co. KG
22 Jan 2002	K013769	V-GNATHOS SUPRA	Metalor Technologies USA
3 Jan 2002	K013506	YELLOW SPECIAL	Metalor Technologies USA
31 Dec 2001	K012839	AUROPAL, ORDER-NO.: 2101	Wieland Edelmetalle GmbH & Co.
19 Dec 2001	K013505	AUROFLUID PLUS	Metalor Technologies USA
21 Nov 2001	K012877	HIGH GOLD PALLADIUM FREE CERAMIC SOLDER	Ivoclar USA, Inc.
2 Nov 2001	K012843	PORTADUR P 2, MODEL #2031	Wieland Edelmetalle GmbH & Co.
1 Nov 2001	K012835	PORTA MAXIMUM, MODEL# 2066	Wieland Edelmetalle GmbH & Co.
1 Nov 2001	K012834	PORTA GEO TI MODEL #2004	Wieland Edelmetalle GmbH & Co.
1 Nov 2001	K012831	BIO PORTADUR, ORDER-NO.:2017	Wieland Edelmetalle GmbH & Co.
1 Nov 2001	K012827	PORTA AURIUM, MODEL 2067	Wieland Edelmetalle GmbH & Co.
1 Nov 2001	K012826	BIOPORTA G, MODEL 2052	Wieland Edelmetalle GmbH & Co.
23 Oct 2001	K012838	ERO50, ORDER-NO.: 2070	Wieland Edelmetalle GmbH & Co.
27 Aug 2001	K011661	CONCORD 88	Gateway Alloys, Inc.
27 Aug 2001	K011659	GPW-SF	Gateway Alloys, Inc.
16 Jul 2001	K011628	CONCORD 82	Gateway Alloys, Inc.
16 Jul 2001	K011626	CONCORD 72	Gateway Alloys, Inc.
22 Jun 2001	K011331	JP CAST 40	Jeneric/Pentron, Inc.
22 Jun 2001	K011330	JP CAST 50	Jeneric/Pentron, Inc.
29 May 2001	K011362	GOLD CORE 73 LS	Jeneric/Pentron, Inc.
10 May 2001	K011036	RD-3008	Heraeus Kulzer, LLC
2 May 2001	K011023	D.SIGN 96	Ivoclar North America, Inc.
2 May 2001	K011022	BIOUNIVERSAL PDF	Ivoclar North America, Inc.
27 Mar 2001	K010611	R & D DESIGNATION AP-047	Jensen Industries, Inc.
27 Mar 2001	K010414	R & D DESIGNATION AP-035	Jensen Industries, Inc.
8 Mar 2001	K010416	HERACERAM 75	Jelenko Co.
9 Feb 2001	K010044	COSMIC	Jeneric/Pentron, Inc.
10 Jan 2001	K003603	BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE	Jelenko Co.
22 Dec 2000	K003635	DW 276 #3	Ivoclar North America, Inc.
21 Dec 2000	K003634	DW 272 #1	Ivoclar North America, Inc.
20 Dec 2000	K003633	DW 277 #4	Ivoclar North America, Inc.
20 Dec 2000	K002854	GOLD CORE POST SOLDER	Jeneric/Pentron, Inc.
19 Dec 2000	K002815	GOLD CORE HF PRE SOLDER	Jeneric/Pentron, Inc.
17 Nov 2000	K003007	GALAXY	Sterngold
2 Nov 2000	K002872	R&D PROJECT DW271#11A	Ivoclar North America, Inc.
25 Oct 2000	K002675	MILLENNIUM EDITION 2000 ACCELERATED ELECTROFORMING SYSTEM	Product Development Industries, Inc.
24 Oct 2000	K002826	EQUITY	Jensen Industries, Inc.
19 Oct 2000	K002645	JEL BIOS PURE	J.F. Jelenko & Co., Inc.
31 Aug 2000	K002222	RD-2104	J.F. Jelenko & Co., Inc.
23 Jun 2000	K001482	AURENORM 75 KF	Aurex SA (Pty) , Ltd.
23 Jun 2000	K001481	PALCERAM 49	Aurex SA (Pty) , Ltd.
21 Jun 2000	K001480	AURECAST 40 B	Aurex SA (Pty) , Ltd.
21 Jun 2000	K001479	PALCERAM 53	Aurex SA (Pty) , Ltd.
20 Jun 2000	K001478	AURECAST SUPER INLAY	Aurex SA (Pty) , Ltd.
20 Jun 2000	K001477	AURELUX Y 84 PREMIUM	Aurex SA (Pty) , Ltd.
23 May 2000	K001041	AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD	Wieland Edelmetalle GmbH & Co.
17 May 2000	K001260	ALLROUND 55 LF	J.F. Jelenko & Co., Inc.
11 May 2000	K001196	JEL BIOS 90 (CODE NAME RD-2401)	J.F. Jelenko & Co., Inc.
28 Apr 2000	K001051	RX EVEREST	Jeneric/Pentron, Inc.
18 Feb 2000	K000360	RX G-UNIVERSAL	Jeneric/Pentron, Inc.
6 Dec 1999	K993508	V-SUPRA PLUS, ALLOY NO. 5025	Metalor Dental USA Corp.
6 Dec 1999	K993507	V-SUPRAGOLD, ALLOY NO. 5024	Metalor Dental USA Corp.
26 Oct 1999	K993175	GOLD CORE 75	Jeneric/Pentron, Inc.
26 Oct 1999	K993173	GOLD CORE 55	Jeneric/Pentron, Inc.
21 Oct 1999	K993152	JEL BIOS 18 (CODE NAME RD- 1214)	J.F. Jelenko & Co., Inc.
21 Oct 1999	K993136	JEL BIOS 10 (CODE NAME RD-1801)	J.F. Jelenko & Co., Inc.
7 Sep 1999	K991901	BIO-97	Jeneric/Pentron, Inc.
2 Apr 1999	K990670	HELIOFORM GOLD-BASED ALLOY	C. Hafner GmbH & Co.
13 Jan 1999	K984140	MAINBOND A	J.F. Jelenko & Co., Inc.
28 Oct 1998	K983082	BEGOCER G	Bego U.S.A.
28 Oct 1998	K983080	AUROLLOYD KF	Bego U.S.A.
23 Oct 1998	K983079	PLATINLLOYD 100	Bego U.S.A.
23 Oct 1998	K983077	BIO PONTOSTAR	Bego U.S.A.
15 Oct 1998	K982606	AUROFLUID CPF	Metalor Dental USA Corp.
13 Aug 1998	K981244	BW-1 (CODE NAME RD-0807)	J.F. Jelenko & Co., Inc.
27 Apr 1998	K980660	BIOGOLD PLUS DENTAL ALLOY	European Dental Imports, Inc.
9 Mar 1998	K980613	PROGOLD ELECTROCOPING SYSTEM	Modern Dental Laboratory USA, LLC
9 Mar 1998	K980597	CARRARA PDF, CARRARA H, CARRARA R	European Dental Imports, Inc.
19 Dec 1997	K972946	AURELUX 77	Aurex Precious Metal Industries (Pty)Ltd
26 Nov 1997	K973372	AUROFILM 2000	Metalor Dental USA Corp.
24 Nov 1997	K973881	PROSPECTOR PLUS (CODE NAME : RD-0508)	J.F. Jelenko & Co., Inc.
14 Oct 1997	K972910	PORS ON LITE	Degussa AG
18 Sep 1997	K972949	AURELUX BIO Y85PF	Aurex Precious Metal Industries (Pty)Ltd
16 Sep 1997	K972943	AURECAST 92	Aurex Precious Metal Industries (Pty)Ltd
5 Sep 1997	K972956	PALCERAM 82SF	Aurex Precious Metal Industries (Pty)Ltd
5 Sep 1997	K972955	PALCERAM 56	Aurex Precious Metal Industries (Pty)Ltd
5 Sep 1997	K972954	PALAUREX 78	Aurex Precious Metal Industries (Pty)Ltd
5 Sep 1997	K972953	PALAUREX 76KF	Aurex Precious Metal Industries (Pty)Ltd
5 Sep 1997	K972952	AUREBOND 51	Aurex Precious Metal Industries (Pty)Ltd
5 Sep 1997	K972951	HIPALLAUR 51	Aurex Precious Metal Industries (Pty)Ltd
5 Sep 1997	K972950	HIPALLAUR 19	Aurex Precious Metal Industries (Pty)Ltd
28 Aug 1997	K972942	AURECAST 83	Aurex Precious Metal Industries (Pty)Ltd
28 Aug 1997	K972941	AURECAST 74	Aurex Precious Metal Industries (Pty)Ltd
26 Aug 1997	K972940	AURECAST BIO 69PF	Aurex Precious Metal Industries (Pty)Ltd
26 Aug 1997	K972939	AURECAST BIO 59PF	Aurex Precious Metal Industries (Pty)Ltd
26 Aug 1997	K972319	AURECAST GF	Aurex Precious Metal Industries (Pty)Ltd
25 Aug 1997	K972938	AURECAST 10	Aurex Precious Metal Industries (Pty)Ltd
25 Aug 1997	K972937	AURECAST 4	Aurex Precious Metal Industries (Pty)Ltd
25 Aug 1997	K972936	AURECAST 2	Aurex Precious Metal Industries (Pty)Ltd
15 Aug 1997	K972632	VERA PD SOLDER	Aalba Dent, Inc.
15 Aug 1997	K972532	AALBA GOLD SOLDER	Aalba Dent, Inc.
4 Jun 1997	K971575	BENCHMARK-IV	J.F. Jelenko & Co., Inc.
20 May 1997	K971574	JELBOND-PDF	J.F. Jelenko & Co., Inc.
20 May 1997	K971292	JEL-71 PDF	J.F. Jelenko & Co., Inc.
30 Apr 1997	K970963	TARGIS ALLOY #7	Ivoclar North America, Inc.
24 Mar 1997	K970068	JELENKO NO.1 (CODE NAME RD-0601)	J.F. Jelenko & Co., Inc.
17 Jan 1997	K964772	AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS)	Ivoclar North America, Inc.
13 Jan 1997	K964950	LA PLATA 28 (PM-28)	Gateway Alloys, Inc.
13 Jan 1997	K964949	AURORA 53	Gateway Alloys, Inc.
13 Jan 1997	K964948	AURORA 52 (PM-01)	Gateway Alloys, Inc.
13 Jan 1997	K964941	EL DORADO 40	Gateway Alloys, Inc.
13 Jan 1997	K964940	TAOS 28	Gateway Alloys, Inc.
20 Dec 1996	K964838	PALLADIA 85 (PM-13)	Gateway Alloys, Inc.
20 Dec 1996	K964837	PACIFIC 56 (CB-40)	Gateway Alloys, Inc.
20 Dec 1996	K964792	LA PLATA 40	Gateway Alloys, Inc.
20 Dec 1996	K964789	LA PLATA 39	Gateway Alloys, Inc.
20 Dec 1996	K964788	EL DORADO 55	Gateway Alloys, Inc.
16 Dec 1996	K964708	SOLDER 615	Gateway Alloys, Inc.
13 Dec 1996	K964158	JEL-40 (CODE NAME RD-0430)	Jelenko Co.
6 Dec 1996	K964573	PIEDMONT 70 (CH-35)	Gateway Alloys, Inc.
6 Dec 1996	K964572	PALLADIA 76	Gateway Alloys, Inc.
6 Dec 1996	K964569	EL DORADO 58	Gateway Alloys, Inc.
6 Dec 1996	K964568	OZARK 46	Gateway Alloys, Inc.
6 Dec 1996	K964567	EL DORADO 75	Gateway Alloys, Inc.
6 Dec 1996	K964566	OZARK 20	Gateway Alloys, Inc.
4 Dec 1996	K964476	DE ORO 77	Gateway Alloys, Inc.
2 Dec 1996	K964477	OZARK 40	Gateway Alloys, Inc.
26 Nov 1996	K964478	OSAGE 76	Gateway Alloys, Inc.
26 Nov 1996	K964465	LA PLATA 34 (PM-25)	Gateway Alloys, Inc.
26 Nov 1996	K964464	PACIFIC 52 (CB-39)	Gateway Alloys, Inc.
20 Nov 1996	K964466	PALLADIA 75 (PM-11)	Gateway Alloys, Inc.
24 Jul 1996	K962326	STERNGOLD BIO-5 (1127210)	Sterngold/Implamed
24 Jul 1996	K962325	QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015)	Sterngold/Implamed
18 Jul 1996	K962303	STERNGOLD CF	Sterngold/Implamed
18 Jul 1996	K962302	PEGASUS DENTAL ALLOY	Sterngold/Implamed
29 May 1996	K960956	STERNGOLD M-PF YELLOW CROWN & BRIDGE ALLOY MODEL 1127200	Sterngold/Implamed
20 May 1996	K961352	285 SL	Argen Precious Metals, Inc.
25 Apr 1996	K961211	ARGELITE 52+	Argen Precious Metals, Inc.
18 Apr 1996	K961285	ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION)	Argen Precious Metals, Inc.

Showing the 200 most recent of 627.

Official records: FDA product classification for EJT · 21 CFR 872.3060.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026