Dental Device Guide
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Prosthetic devices · 21 CFR 872 Subpart D

Amalgam Alloy

FDA device type “Alloy, Amalgam”.

FDA codeEJJClass221 CFR872.3070Pathway510(k)
Companies listing it
208 makers
Brands and models
49
510(k) clearances
740 in five years
FDA name
Alloy, Amalgam
1976: 11977: 21978: 31979: 21980: 21981: 21982: 91984: 11985: 11987: 11988: 21989: 41990: 61991: 31992: 21993: 41994: 41995: 41996: 21997: 41998: 41999: 12000: 32001: 12002: 12003: 32005: 219801990200020102020

510(k) clearances per year, 1976–2026

Companies that list EJJ

20 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Dentsply Sirona, Inc.United StatesMaker—1482026
Sybron Dental SpecialtiesUnited StatesMakerContour · Tytin · Tytin FC2032026
Ivoclar Vivadent, AGUnited StatesMakerValiant · Valiant PhD · Valiant Sure-Cap942026
Sdi LimitedAustraliaMakerBenco Admix · Benco Spherical · Galloy · GS 80 · +1082022
New Stetic, SAColombiaMakerMicronic · NU Alloy DP · Nu Alloy DP Active52026
Worldwork S.R.LItalyMakerALLOY, AMALGAM DENTAL AMALGAM12023
Silmet , Ltd.IsraelMakerAlloy regular · Amalgam dental alloy · Avalloy · DEXITER DISPERSED AMALGAM · +1032011
DMG America, L.L.C.United StatesMakerAlloy, Amalgam12013
Jersey Dental SuppliesUnited StatesRepacker / relabelerNEW STETIC DENTAL AMALGAM ALLOY · TYTIN——
TitanLinks Logistics LLCUnited StatesRepacker / relabelerAmalgam · Dental amalgam——
Patterson Companies, Inc.United StatesForeign exporterPatterson® Admix Alloy Capsules · Patterson® Spherical Alloy Amalgam Capsules——
Soher Med LimitedHong Kong SAR ChinaForeign exporterAmalgam——
Samtrade Supplies Inc.CanadaForeign exporterTytin Amalgam——
Bina LimitedBelizeForeign exporterAlloy, amalgam——
Sanicure BVNetherlandsForeign exporter———
Caribbean Dental Products Corp.United StatesRepacker / relabelerAMALGAM——
CBR Enterprise LimitedHong Kong SAR ChinaForeign exporter———
3D Dental Designs and Development LLCUnited StatesContract manufacturer———
Mainline Medical Dental SupplyCanadaForeign exporter———
Oketz Logistics LLCUnited StatesRepacker / relabeler———

510(k) clearances

Decided510(k)DeviceApplicant
15 Nov 2005K053114SILVERFILDunia Perwira Manufacturing Sdn. Bhd.
2 May 2005K051010SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70Septodont
12 Nov 2003K033434BESTALOYWe Dong Myung Dental Industrial Co., Ltd.
6 Aug 2003K032152BENCO ADMIXSouthern Dental Industries, Inc.
29 Jul 2003K031658BENCO SPHERICALSouthern Dental Industries, Inc.
7 May 2002K020452HIGH SILVER CONVENTIONALAb Ardent
16 Aug 2001K011801FUTURA TOPCAP NON GAMMA-2Ab Ardent
31 Oct 2000K002811ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOYNordiska Dental AB
31 Oct 2000K002810ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOYNordiska Dental AB
31 Oct 2000K002808ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOYNordiska Dental AB
11 Aug 1999K991481PARAGONLancer Orthodontics, Inc.
19 Oct 1998K982671SECURALLOYSpecialites Septodont
24 Aug 1998K982460VIVACAP HRAb Ardent
24 Aug 1998K982458VIVALLOY HRAb Ardent
24 Aug 1998K982456AMALCAP PLUSAb Ardent
17 Dec 1997K974035CENTURY ALLOYDentsply Intl., Inc.
7 Oct 1997K973086PLA-96PSouthern Dental Industries, Inc.
3 Oct 1997K973088PLS-96PSouthern Dental Industries, Inc.
6 Jan 1997K964192ARDENT NON GAMMA-2 70Ardent Production Development
10 Dec 1996K964775ARDENT FUTURA NON GAMMA-2Ardent Production Development
24 Jan 1996K955285GALLOYSouthern Dental Industries, Inc.
25 Aug 1995K952670CUPRALLOYWykle Research, Inc.
6 Jun 1995K951663TYTIN RKerr Corporation (Danbury)
25 May 1995K951865ULTRA SPHERICAL AMALGAM ALLOYGoldsmith & Revere, Inc.
2 May 1995K951511TYTIN ADMIXKerr Corporation (Danbury)
14 Jul 1994K942430AGALLOY, DISALLOY, EPSILON AND LAMBDAFen Dental Mfg., Inc.
29 Apr 1994K940675SYBRALOYSybron Dental Specialties
11 Mar 1994K935535TYTINKerr Corporation (Danbury)
10 Feb 1994K936113INDIPERSEIndisperse Distributing, Inc.
1 Oct 1993K933309PRINCEGoldsmith & Revere, Inc.
15 Mar 1993K922100DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILEGraham Medical Products
12 Feb 1993K923640GK DENTAL AMALGAM ALLOYThe Patron Trading Corp.
11 Jan 1993K923384ANA 70 DISPERSED PHASE DENTAL ALLOY -- MODIFIEDL.C. Dental
10 Aug 1992K921538AMALGAPHASESaskan Amalgam Alloys, Inc.
2 Mar 1992K915654KERALLOY-D CAPSWilde-USA, Inc.
27 Dec 1991K913175MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULESG-C Intl. Corp.
13 Nov 1991K912992KERALLOY NON-GAMMA 2 AMALGAMWilde-USA, Inc.
29 Mar 1991K905204DW 236Ivoclar North America, Inc.
17 Dec 1990K905205DW 235Ivoclar North America, Inc.
13 Jul 1990K902249LUXALLOY 50 (POWDER, TABLETS, PREDOSED CAPSULES)Degussa AG
13 Jul 1990K902248LUXALLOY CAPS (PREDOSED CAPSULES)Degussa AG
13 Jul 1990K902247ARTALLOY (POWDER)Degussa AG
1 Jun 1990K901911VIVAALLOY HR (AMALGAM)Ivoclar North America, Inc.
27 Apr 1990K901256AMALCAP PLUSIvoclar North America, Inc.
9 May 1989K890662PENT CAPSJeneric/Pentron, Inc.
5 May 1989K890682OROSPHERE PLUSJeneric/Pentron, Inc.
2 May 1989K890681OROSPHERE HCDPJeneric/Pentron, Inc.
17 Apr 1989K891390GK ALLOYChina Link, Inc.
21 Apr 1988K881333OLYMPIA ALLOYJ.F. Jelenko & Co., Inc.
18 Mar 1988K875344HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOYKulzer, LLC
20 May 1987K870230ALLOY FOR DENTAL AMALGAM LUXALLOY NON GAMMA 2Degussa Dental, Inc.
25 Mar 1985K844653LIMI ALLOYG-C Intl. Corp.
16 Mar 1984K840297COLTENE ORALLOY MAGICAPSColtene AG
10 Nov 1982K823098REX-CAPSBauer, Cheng & Associates, Inc.
26 Oct 1982K822951SPHEREX E.C.T.Jeneric Ind.
20 Jul 1982K821971VALULINE* AMALGAM ALLOYJohnson & Johnson Professionals, Inc.
7 Jun 1982K821226DENTAL AMALGAM ALLOYDental Alloyers Intl., Inc.
24 May 1982K821222GOLDSMITH & REVERE TENARY ALLOYGoldsmith & Revere, Inc.
9 Apr 1982K820738LUSTRALLOYHoyt Laboratories
25 Mar 1982K820617DISPERSED PHASE ALLOYGoldsmith & Revere, Inc.
11 Mar 1982K820389A DENTAL AMALGAM ALLOY (UNNAMEDDentsply Intl., Inc.
24 Feb 1982K820181SYBRON/KERR CONTOURSybron Corp.
16 Nov 1981K812827ORBIC* SPHERICAL ALLOYJohnson & Johnson Professionals, Inc.
23 Apr 1981K810907COLTENE ORALLYColtene AG
27 Aug 1980K801639PERMITE DENTAL AMALGAM ALLOYSouthern Dental Industries, Inc.
13 Aug 1980K801690VALIANTL.D. Caulk Co.
5 Jun 1979K790874AMALCAP-NON-GAMMA-2Vivadent (Usa), Inc.
11 Apr 1979K790448EASYFILGeneral Refineries, Inc.
21 Aug 1978K781242ALLOY, AMALGAM, DISP. CAPSULELee Pharmaceuticals
27 Jul 1978K780997AMALGAM ALLOYSyntex Corp.
22 Jun 1978K780967LEE-ALLOYLee Pharmaceuticals
22 Aug 1977K771403EASE (MODIFICATION TO)L.D. Caulk Co.
3 Aug 1977K771383ALLOY DISPOS-A-CAP DENTAL SCHOOL CAPJohnson & Johnson Professionals, Inc.
15 Nov 1976K760980DENTAL ALLOYAdp Intl., Inc.

Official records: FDA product classification for EJJ · 21 CFR 872.3070.

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