Prosthetic devices · 21 CFR 872 Subpart D

Alloy Other Noble Metal

FDA device type “Alloy, Other Noble Metal”.

FDA codeEJSClass221 CFR872.3060Pathway510(k) exemptCategoryDental alloys

Companies listing it: 4229 makers
Brands and models: 510
510(k) clearances: 1940 in five years
FDA name: Alloy, Other Noble Metal

510(k) clearances per year, 1976–2026

Companies that list EJS

42 companies currently list this device type with FDA.

Company	Country	Role	Brands and models listed	Clearances	Latest
Aidite (Qinhuangdao) Technology Co., Ltd	China	Maker	Aidite Firing Paste	16	2026
Ivoclar Vivadent, AG	United States	Maker	Aquarius · Aquarius Ceramic Solder · Capricorn 15 · d.SIGN 53 · +19	94	2026
Shandong Huge Dental Material Corporation	China	Maker	Firing Paste	8	2026
The Argen Corporation	United States	Maker	ACCU-STAR · ALBACAST · ALLROUND 37 · ALLROUND 38 · +409	11	2024
Leone S.P.A.	Italy	Maker	Noble alloys	4	2025
Hunan Ceramaster Material Technology Co., Ltd.	China	Maker	Firing Paste	1	2024
Aalba Dent, Inc.	United States	Maker	VERA SOLDER	27	2004
Sterngold	United States	Maker	Phoenix & 2713 · Stern 1 · Stern 66 · Sterngold Bio-4 · +1	24	2017
Jensen Industries, Inc.	United States	Maker	Advantage · Blaze · Castell · Integrity · +17	17	2019
Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO	Germany	Maker	AuroLloyd M · BegoPal 300 · BegoPal S · BegoStar · +2	4	2013
Cendres+Metaux SA	Switzerland	Maker	—	2	2020
Qinhuangdao Audental Metal Technology Co., Ltd.	China	Maker	Audental 15; Audental 40+; Audental 30;Audental 35; Audental 43;Audental 02;Audental 54;Audental 61; · Audental Pal;Audental Pal 2;Audental 60;Audental Pd80;Audental Pd80+;Audental Pd76;Audental Pd75; · Audental Pd49;Audental A10;Audental A20;Audental A35;Audental A25;Audental A25+;Audental U40;Audental 43+; · Audental Pd70;Audental Pd71;Audental Pd61;Audental Pd58;Audental Pd55;Audental Pd50; · +2	1	2020
Wright Health Group	United Kingdom	Maker	Alloy shots and rods Dentoweld	1	2013
Aurident, Inc.	United States	Maker	Aurident Alloys	1	2004
Dentaurum GmbH & Co. KG	Germany	Maker	DentAurum Bio · DentAurum Classic · DentAurum LFC	—	—
Solventum US LLC	United States	Maker	SILVER SOLDER	—	—
one day dental partner	South Korea	Maker	kage ALLOY, OTHER NOBLE METAL	—	—
Digital Dental Depot Limited	Hong Kong SAR China	Maker	ALLOY, OTHER NOBLE METAL · EJS / ALLOY, OTHER NOBLE METAL	—	—
Fseven Dental Technology Zhuhai Co.,ltd	China	Maker	ALLOY, OTHER NOBLE METAL	—	—
Digital Dental Depot	China	Maker	alloy, other noble metal	—	—
DEPRAG High tech Materials ( Zhengzhou ) Co.,Ltd.	China	Maker	Firing paste	—	—
Shenzhen HLD Dental&Technology Co.,Ltd	China	Maker	Heraeus; Argen	—	—
Worldlabusa	United States	Maker	Other noble alloy	—	—
Shenzhen Times Dental Lab	China	Maker	Times Dental Custom Restorations	—	—
Sunrise Dental Laboratory, Ltd.	Hong Kong SAR China	Maker	Ivoclar Vivadent	—	—
Forbes Dental Prosthetics Inc.	Philippines	Maker	FORBES DENTAL	—	—
Liaoning Xinaite Technology Co.,Ltd	China	Maker	Firing Paste	—	—
Strategy Milling, LLC	United States	Maker	SM-OG High Noble Alloy	—	—
Shen FU Arts Lab	China	Maker	—	—	—
Young Innovations Inc	United States	Contract manufacturer	Silver Solder	23	2025
Imicryl Dis Malzemeleri Sanayi VE Ticaret AS	Türkiye	Manufacturer	DENTAL ALLOY	5	2022
Rmo, Inc.	United States	Manufacturer	Bridging wire; Silver Solder	1	1990
Patterson Companies, Inc.	United States	Foreign exporter	Patterson Alloy	—	—
DDS Dentalab	United States	Repacker / relabeler	ARTIFICIAL TEETH	—	—
Shaw Dental Laboratories Corp.	United States	Repacker / relabeler	Other Nobel Metal	—	—
Pan-Am Dental, Inc.	United States	Contract manufacturer	ALLOY, OTHER NOBLE METAL	—	—
Reliable Dental Studio, Inc.	United States	Remanufacturer	—	—	—
DigiSmiles Lab	United States	Repacker / relabeler	Alloy, Other Noble Metal	—	—
Mountain Dental Lab Service Inc	United States	Repacker / relabeler	SHEN FU ARTS LAB	—	—
Damore Dental Lab LLC	United States	Repacker / relabeler	Dental appliance	—	—
Onestopdentalstudio Inc	United States	Repacker / relabeler	ALLOY, OTHER NOBLE METAL	—	—
Global Dentech Inc.	United States	Lister	ARTIFICIAL TEETH	—	—

510(k) clearances

Decided	510(k)	Device	Applicant
19 Aug 2004	K041433	BRIGHT GOLD XH	Ivoclar Vivadent, AG
5 Mar 2004	K040436	SIMIDUR SUPERIOR	Wieland Dental + Technik GmbH & Co. KG
19 Sep 2002	K022252	STERNGOLD 1, MODEL 1127781	Sterngold
18 Sep 2002	K022469	ECO E4	Wieland Dental + Technik GmbH & Co. KG
16 May 2002	K021367	STERNGOLD 66, MODEL #1180230	Sterngold
15 Mar 2002	K020195	SIMIDUR S1S	Wieland Dental + Technik GmbH & Co. KG
15 Mar 2002	K020194	SIMIDUR KF PLUS	Wieland Dental + Technik GmbH & Co. KG
15 Mar 2002	K020192	SIMIDUR S2	Wieland Dental + Technik GmbH & Co. KG
22 Feb 2002	K014042	D.SIGN 84	Ivoclar Vivadent, AG
7 Feb 2002	K013809	D.SIGN 59	Ivoclar Vivadent, AG
30 Jan 2002	K014082	D.SIGN 53, MODEL NA1012204	Ivoclar Vivadent, AG
20 Nov 2001	K012841	DUO PAL 6, ORDER-NO.: 2154	Wieland Edelmetalle GmbH & Co.
1 Nov 2001	K012828	PORTA SMK 82, MODEL 2032	Wieland Edelmetalle GmbH & Co.
23 Oct 2001	K012840	EURO 45, ORDER-NO.: 2064	Wieland Edelmetalle GmbH & Co.
22 Aug 2001	K012303	JEL-20	J.F. Jelenko & Co., Inc.
20 Dec 2000	K003632	DW 273 #1	Ivoclar North America, Inc.
5 Jul 2000	K001469	R&D PROJECT DW269#25	Ivoclar North America, Inc.
6 Apr 2000	K000532	JEL 15	J.F. Jelenko & Co., Inc.
9 Dec 1999	K993475	AUROFLUID M, ALLOY NO. 5315	Metalor Dental USA Corp.
8 Dec 1999	K993506	PAGALINOR 4 , ALLOY NO. 5440	Metalor Dental USA Corp.
8 Dec 1999	K993505	V-DELTA SPECIAL, ALLOY NO. 5154	Metalor Dental USA Corp.
2 Dec 1999	K993474	DELTAPAL, ALLOY NO. 5161	Metalor Dental USA Corp.
17 Mar 1999	K984587	ALLROUND-E (CODE NAME RD 1710)	J.F. Jelenko & Co., Inc.
12 Feb 1999	K990078	D-SIGN IV (R&D PROJECT DW265#37)	Ivoclar North America, Inc.
12 Feb 1999	K990077	D-SIGN III (R&D PROJECT DW264#7)	Ivoclar North America, Inc.
19 Jan 1999	K984451	D-SIGN I (R&D PROJECT DW263 #24)	Ivoclar North America, Inc.
28 Oct 1998	K983081	BEGOPAL 300	Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO
23 Oct 1998	K983078	BEGOPAL	Bego U.S.A.
13 Aug 1998	K981257	JELFINE-52 (CODE NAME RD-0901)	J.F. Jelenko & Co., Inc.
1 Jul 1998	K981247	SILCAST (CODE NAME RD-0118)	J.F. Jelenko & Co., Inc.
18 May 1998	K981002	ORION WX DENTAL ALLOY	European Dental Imports, Inc.
18 May 1998	K981001	ORION VESTA DENTAL ALLOY	European Dental Imports, Inc.
1 May 1998	K980661	CERA E DENTAL ALLOY	European Dental Imports, Inc.
26 Nov 1997	K972945	AURENORM 68	Aurex Precious Metal Industries (Pty)Ltd
19 Nov 1997	K973288	STABILOR HN	Degussa AG
5 Sep 1997	K972534	ALFALLOY	Aalba Dent, Inc.
5 Sep 1997	K972533	VERA SOLDER	Aalba Dent, Inc.
18 Aug 1997	K972683	V-DELTA 450	Metalor Dental USA Corp.
5 Mar 1997	K970045	SOLARO 33	Metalor Dental USA Corp.
5 Mar 1997	K970044	AUROFLUID 22	Metalor Dental USA Corp.
16 Dec 1996	K964713	SOLDER GPW	Gateway Alloys, Inc.
16 Dec 1996	K964707	SOLDER 585	Gateway Alloys, Inc.
16 Dec 1996	K964706	SOLDER 650	Gateway Alloys, Inc.
16 Dec 1996	K964705	SOLDER GPY	Gateway Alloys, Inc.
24 Jul 1996	K962324	STERNGOLD U-CPF METAL ALLOY (1067800)	Sterngold/Implamed
23 Jul 1996	K962304	STERNGOLD BIO-4	Sterngold/Implamed
18 Jul 1996	K962301	STERNGOLD G-HARD METAL ALLOY	The Stern Metals Co., Inc.
22 Jun 1994	K941625	DW234 #29	Rms Div.
4 Feb 1994	K934757	CU-FREE & LTA	Jeneric/Pentron, Inc.
6 Jan 1994	K935388	CERAPALL 4CF	Metalor
10 Dec 1993	K934773	ARGELITE A	Argen Precious Metals, Inc.
20 Oct 1993	K933563	VS 1A	Metalor Dental USA Corp.
27 May 1993	K926147	GOLD-PLATINUM BASED CASTING ALLOY	Jeneric/Pentron, Inc.
27 May 1993	K926146	BIO C & B	Jeneric/Pentron, Inc.
27 May 1993	K925331	CORRECT AND CORRECT FIT II	Jeneric/Pentron, Inc.
5 May 1993	K926145	NUGOLD 2%	Jeneric/Pentron, Inc.
1 Mar 1993	K924292	CERAPALL 6 -- MODIFIED	Metalor Dental USA Corp.
26 Feb 1993	K922958	KB58-KF	Jeneric/Pentron, Inc.
23 Dec 1992	K922955	ZENON PLUS	Jeneric/Pentron, Inc.
21 Dec 1992	K925273	GDC 3445	Deringer-Ney, Inc.
4 Nov 1992	K923644	DW243-64	Ivoclar USA, Inc.
14 Sep 1992	K922957	PARAGON	Jeneric/Pentron, Inc.
14 Sep 1992	K922956	KB40-KF	Jeneric/Pentron, Inc.
5 Aug 1992	K922451	LEGACY-XT	J.F. Jelenko & Co., Inc.
5 Aug 1992	K922450	BENCHMARK C	J.F. Jelenko & Co., Inc.
5 Aug 1992	K922449	PA-400	J.F. Jelenko & Co., Inc.
5 Aug 1992	K922448	BENCHMARK I	J.F. Jelenko & Co., Inc.
5 Aug 1992	K922447	BENCHMARK III	J.F. Jelenko & Co., Inc.
5 Aug 1992	K922446	ACCU-STAR	J.F. Jelenko & Co., Inc.
26 May 1992	K921445	DEGUBOND PLUS	Degussa AG
26 May 1992	K921419	DEVA PLUS	Degussa AG
5 May 1992	K920922	GDC 3367	Deringer-Ney, Inc.
21 Apr 1992	K920613	DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL	Ivoclar North America, Inc.
21 Apr 1992	K915165	ARGEBOND 77+	Argen Precious Metals, Inc.
19 Mar 1992	K920887	GDC-3338, DENTAL SOLDER ALLOY	Deringer-Ney, Inc.
2 Mar 1992	K920560	DW236-34 ALLOY FOR PORCELAIN FUSED TO METAL	Invoclar North America, Inc.
13 Nov 1991	K914627	PLATINUM FOIL PLATINUM MILING WAFER	Metalor Dental USA Corp.
13 Nov 1991	K913860	ULTRACROWN(TM) PD ALLOY POST-SOLDER	Dentsply Intl., Inc.
13 Nov 1991	K913704	ARGEBOND 80	Argen Precious Metals, Inc.
2 Oct 1991	K913069	DW238 #228-04B	Ivoclar North America, Inc.
2 Oct 1991	K913068	DW238 #228-34A	Ivoclar North America, Inc.
13 Sep 1991	K913070	X-L (DW228-14A) AND X-LX (DW228-24A)	Ivoclar North America, Inc.
6 Sep 1991	K913232	ULTRACROWN(TM) PD DENTAL ALLOY	Dentsply Intl., Inc.
20 Aug 1991	K912493	DEGUBOND LITE	Degussa AG
16 Aug 1991	K911674	CERAPLUS	Metalor Dental USA Corp.
16 Aug 1991	K911669	CERAPALL 6	Metalor Dental USA Corp.
9 Aug 1991	K912308	STANDARD S32	Metalor Dental USA Corp.
9 Aug 1991	K912307	STANDARD S31	Metalor Dental USA Corp.
9 Aug 1991	K912305	STANDARD S3	Metalor Dental USA Corp.
9 Aug 1991	K912302	VACU 2	Metalor Dental USA Corp.
30 Jul 1991	K912195	PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE	Jelenko Co.
30 Jul 1991	K912194	PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE	Jelenko Co.
10 Jul 1991	K911671	CERADELTA	Metalor Dental USA Corp.
2 Jul 1991	K912315	V-DELTA S1	Metalor Dental USA Corp.
2 Jul 1991	K912314	800 SOLDER	Metalor Dental USA Corp.
2 Jul 1991	K911545	V-DELTA	Metalor Dental USA Corp.
27 Jun 1991	K911677	SELECTOR 3	Metalor Dental USA Corp.
27 Jun 1991	K911675	PAGALIN 2	Metalor Dental USA Corp.
27 Jun 1991	K911668	CERAPALL 2	Metalor Dental USA Corp.
26 Jun 1991	K912309	STANDARD S33	Metalor Dental USA Corp.
26 Jun 1991	K912306	STANDARD S4	Metalor Dental USA Corp.
26 Jun 1991	K912304	STANDARD S2	Metalor Dental USA Corp.
26 Jun 1991	K912303	STANDARD S1	Metalor Dental USA Corp.
26 Jun 1991	K912300	VS11	Metalor Dental USA Corp.
26 Jun 1991	K912299	VS1B	Metalor Dental USA Corp.
26 Jun 1991	K912298	VS1	Metalor Dental USA Corp.
18 Jun 1991	K911757	MAXIBOND	Argen Precious Metals, Inc.
18 Jun 1991	K911670	CERAPALL	Metalor Dental USA Corp.
30 Apr 1991	K910467	ARGIPLUS	Argen Precious Metals, Inc.
17 Apr 1991	K904876	DW237	Ivoclar North America, Inc.
17 Dec 1990	K903971	ARGENCO 26B	Argen Precious Metals, Inc.
13 Aug 1990	K903060	ARGENCO 34	Argen Precious Metals, Inc.
13 Aug 1990	K903009	ARGENCO III	Argen Precious Metals, Inc.
7 Aug 1990	K902665	ARGENCO Y (TYPE III/IV DENTAL ALLOY CROWN/BRIDGE	Argen Precious Metals, Inc.
28 Jun 1990	K902376	DW231 DENTAL ALLOY	Ivoclar North America, Inc.
25 Apr 1990	K901099	PROTOCOL (ALLOY)	Ivoclar North America, Inc.
17 Mar 1989	K890811	RX APF (CASTING ALLOY)	Jeneric/Pentron, Inc.
6 Oct 1988	K883511	ALBABOND E	Degussa Dental, Inc.
22 Sep 1988	K883509	HERAEUS DG 63	Degussa Dental, Inc.
15 Sep 1988	K883510	DEGUPAL 4	Degussa Dental, Inc.
15 Sep 1988	K883507	HERAEUS C SPECIAL	Degussa Dental, Inc.
6 Sep 1988	K883512	HERAEUS WHITE	Degussa Dental, Inc.
8 Feb 1988	K874821	LUNAR CASTING ALLOY FOR PORCELAIN-FUSED-TO-METAL	Deringer-Ney, Inc.
27 Oct 1987	K873373	SINTERLOY	Denpac Corp.
15 Apr 1987	K871288	GDC 1830 CASTING ALLOY	Deringer-Ney, Inc.
3 Nov 1986	K864162	DEGUPAL	Degussa Dental, Inc.
26 Aug 1986	K862856	PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR	Austenal Dental, Inc.
26 Mar 1986	K860964	WHITE SILVER SOLDER AND YELLOW SILVER SOLDER	Austenal Dental, Inc.
25 Mar 1986	K855182	ALLOY FOR METAL CROWN & BRIDGE YELLOW PD #46 & #65	Williams Gold Refining Co., Inc.
20 Mar 1986	K860439	DW217 #18 CROWN/BRIDGE & DW218 #24 CERAMIC ALLOYS	Williams Gold Refining Co., Inc.
17 Mar 1986	K860299	REALOR ALLOY	Degussa Dental, Inc.
17 Mar 1986	K860119	GDC 1742 (A CASTING ALLOY FOR DENTAL RESTORATIONS)	Deringer-Ney, Inc.
23 Aug 1985	K852093	ALLOY 7	Williams Gold Refining Co., Inc.
31 Jul 1985	K852347	DENTAL CASTING ALLOY GDC 1686	Deringer-Ney, Inc.
4 Jun 1985	K851648	HERACOR SYSTEM HERACOR PLATINUM FOIL, BLENDGOLD NE	Heraeus Dental Gold Corp.
18 Mar 1985	K850699	SPARTAN -ALLOY FOR PORCELAIN FUSED TO METAL	Williams Gold Refining Co., Inc.
8 Feb 1985	K850193	PORS-ON HF-SOLDER(PORCELAIN DENTAL ALLOYS)	Degussa Dental, Inc.
8 Feb 1985	K850103	GDC-1489 A CASTING ALLOY	Deringer-Ney, Inc.
8 Feb 1985	K850102	GDC-1433 A CASTING ALLOY	Deringer-Ney, Inc.
8 Feb 1985	K850101	GDC-1629 A CASTING ALLOY	Deringer-Ney, Inc.
1 May 1984	K840563	RX C & B 20	Jeneric Ind.
1 May 1984	K840561	RX ELAN	Jeneric Ind.
30 Mar 1984	K840014	CHEMODENT CERAMIC METAL	Chemodent Metal Co.
24 Jan 1984	K833774	NATURELLE II & LITE II-N72-N74-L	Jeneric Ind.
29 Dec 1983	K833596	GDC 1448 DEVELOPMENT NAME	Deringer-Ney, Inc.
29 Dec 1983	K833434	CERAMCO * HIGH FUSING FOIL SOLDER	Johnson & Johnson Professionals, Inc.
26 Dec 1983	K833445	DEGUPLUS 2	Degussa Dental, Inc.
28 Oct 1983	K833050	RX 90	Jeneric Ind.
28 Oct 1983	K833049	PALLADENT	Jeneric Ind.
4 Oct 1983	K832425	GREAT LAKES PASTE SOLDER	Great Lakes Orthodontics, Ltd.
29 Sep 1983	K832530	DEVA 4	Degussa Dental, Inc.
31 Aug 1983	K832253	X-704	Unitek Corp.
15 Jun 1983	K831097	CONCERTO	Unitek Corp.
15 Jun 1983	K831096	STROMA II	Unitek Corp.
10 Nov 1982	K823100	RX 91	Bauer, Cheng & Associates, Inc.
10 Nov 1982	K823097	NATURELLE	Bauer, Cheng & Associates, Inc.
10 Nov 1982	K823084	CHALLENGER	Bauer, Cheng & Associates, Inc.
22 Oct 1982	K822950	RX UNIVERSAL	Jeneric Ind.
30 Aug 1982	K822419	NEW CROWN AND BRIDGE ALLOY NO. DW196	Williams Gold Refining Co., Inc.
13 Jul 1982	K821798	82 ALLOY	J. Aderer, Inc.
6 Jul 1982	K821832	DEGUCAST U	J. Aderer, Inc.
14 Jun 1982	K821590	PORS-ON	J. Aderer, Inc.
14 Jun 1982	K821572	DUALLOR 'R'	J. Aderer, Inc.
9 Jun 1982	K821510	A THENIUM	Williams Gold Refining Co., Inc.
9 Jun 1982	K821407	DEVA M	J. Aderer, Inc.
28 May 1982	K821299	CER-MATE	J. Aderer, Inc.
10 May 1982	K821022	PRECIOUS METAL ALLOYS	J. Aderer, Inc.
5 May 1982	K820955	BOND-ON	J. Aderer, Inc.
19 Mar 1982	K820530	T-IV ELITE ALLOY	Howmedica Corp.
11 Mar 1982	K820434	CLASS OF CASTING ALLOYS TYPE III OR ALT	Howmedica Corp.
11 Mar 1982	K820433	CLASS OF CASTING ALLOYS TYPE II OR ALTER	Howmedica Corp.
11 Mar 1982	K820432	CLASS OF CASTING ALLOYS TYPE I OR ALTER	Howmedica Corp.
2 Mar 1982	K820408	CLASS OF CASTING ALLOYS TYPE IV OR ALT	Howmedica Corp.
2 Mar 1982	K820407	CLASS OF PRECIOUS METAL CASTING ALLOYS	Howmedica Corp.
7 Jan 1982	K813418	INZOMA NP	J. Aderer, Inc.
31 Dec 1981	K813200	GDC-1136 CASTING ALLOY FOR PORCELAIN-FU	Ney
18 Aug 1981	K812101	BAK-ON SP PORCELAIN ALLOY	Johnson & Johnson Professionals, Inc.
28 Jul 1981	K811563	PRESOLDER FOR NON-PRECIOUS DENTAL ALLOYS	Williams Gold Refining Co., Inc.
17 Mar 1981	K810380	HOWMEDICA T-III G ALLOY	Howmedica Corp.
21 Jul 1980	K801277	GDC 934	Deringer-Ney, Inc.
4 Jun 1980	K801009	HOWMEDICA WHITE C&B ALLOY	Dental Laboratory Products Div.
8 May 1980	K800951	CASTA-LLOY	U.S. Shizai Corp.
2 May 1980	K800994	AUSTRY ALLOY(DENTAL BAKE-ON ALLOY)	Howmedica Corp.
30 Nov 1979	K792274	TEMPO	Deringer-Ney, Inc.
20 Nov 1979	K792008	HOWMEDICA AG-PD CROWN AND BRIDGE ALLOY	Howmedica Corp.
20 Nov 1979	K791973	HOWMEDICA A-35 DENTAL ALLOY	Howmedica Corp.
10 Aug 1979	K791005	CHEMODENT CERAMIC METAL	Chemodent Dental Laboratory
1 May 1979	K790641	GDC-685	Deringer-Ney, Inc.
26 Feb 1979	K790097	SALIVAN & SALIVAN BROWN	Den-Mat Corp.
26 Feb 1979	K790096	SALIVAN PARAEIGHT TOUGHNESS	Den-Mat Corp.
26 Aug 1977	K771596	WILL-CERAM W-3	Williams Gold Refining Co., Inc.
15 Jul 1977	K771145	WILL-CERAM W-2	Williams Gold Refining Co., Inc.
15 Oct 1976	K760783	BIOBOND-CROWN & BRIDGE CERAMIC BONDING	Dentsply Intl., Inc.
23 Aug 1976	K760379	DENTAL AMALGAM ALLOY (SPHERICAL II)	L.D. Caulk Co.

Official records: FDA product classification for EJS · 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