Product Code: EJJ FDA class 2 21 CFR 872.3070

Alloy, Amalgam

Dental

Amalgam Alloy is a dental restorative material consisting of a silver-based alloy powder, historically combined with mercury to form a plastic amalgam mass that hardens into a durable restorative for posterior teeth. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance and compliance with special controls given material biocompatibility considerations. The product code is EJJ, regulated under 21 CFR 872.3070 in the Dental (DE) specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: EJJ
Device Class: FDA class 2
Regulation Number: 872.3070
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 74 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K053114	SILVERFIL	Nov 15, 2005	Substantially Equivalent	Dunia Perwira Manufacturing Sdn. Bhd.
K051010	SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70	May 02, 2005	Substantially Equivalent	Septodont
K033434	BESTALOY	Nov 12, 2003	Substantially Equivalent	We Dong Myung Dental Industrial Co., Ltd.
K032152	BENCO ADMIX	Aug 06, 2003	Substantially Equivalent	Southern Dental Industries, Inc.
K031658	BENCO SPHERICAL	Jul 29, 2003	Substantially Equivalent	Southern Dental Industries, Inc.
K020452	HIGH SILVER CONVENTIONAL	May 07, 2002	Substantially Equivalent	Ab Ardent
K011801	FUTURA TOPCAP NON GAMMA-2	Aug 16, 2001	Substantially Equivalent	Ab Ardent
K002811	ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY	Oct 31, 2000	Substantially Equivalent	Nordiska Dental AB
K002810	ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY	Oct 31, 2000	Substantially Equivalent	Nordiska Dental AB
K002808	ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY	Oct 31, 2000	Substantially Equivalent	Nordiska Dental AB
K991481	PARAGON	Aug 11, 1999	Substantially Equivalent	Lancer Orthodontics, Inc.
K982671	SECURALLOY	Oct 19, 1998	Substantially Equivalent	Specialites Septodont
K982460	VIVACAP HR	Aug 24, 1998	Substantially Equivalent	Ab Ardent
K982458	VIVALLOY HR	Aug 24, 1998	Substantially Equivalent	Ab Ardent
K982456	AMALCAP PLUS	Aug 24, 1998	Substantially Equivalent	Ab Ardent
K974035	CENTURY ALLOY	Dec 17, 1997	Substantially Equivalent	Dentsply Intl.
K973086	PLA-96P	Oct 07, 1997	Substantially Equivalent	Southern Dental Industries, Inc.
K973088	PLS-96P	Oct 03, 1997	Substantially Equivalent	Southern Dental Industries, Inc.
K964192	ARDENT NON GAMMA-2 70	Jan 06, 1997	Substantially Equivalent	Ardent Production Development
K964775	ARDENT FUTURA NON GAMMA-2	Dec 10, 1996	Substantially Equivalent	Ardent Production Development
K955285	GALLOY	Jan 24, 1996	Substantially Equivalent	Southern Dental Industries, Inc.
K952670	CUPRALLOY	Aug 25, 1995	Substantially Equivalent	Wykle Research, Inc.
K951663	TYTIN R	Jun 06, 1995	Substantially Equivalent	Kerr Corporation (Danbury)
K951865	ULTRA SPHERICAL AMALGAM ALLOY	May 25, 1995	Substantially Equivalent	Goldsmith & Revere, Inc.
K951511	TYTIN ADMIX	May 02, 1995	Substantially Equivalent	Kerr Corporation (Danbury)
K942430	AGALLOY, DISALLOY, EPSILON AND LAMBDA	Jul 14, 1994	Substantially Equivalent	Fen Dental Mfg., Inc.
K940675	SYBRALOY	Apr 29, 1994	Substantially Equivalent	Sybron Dental Specialties, Inc.
K935535	TYTIN	Mar 11, 1994	Substantially Equivalent	Kerr Corporation (Danbury)
K936113	INDIPERSE	Feb 10, 1994	Substantially Equivalent	Indisperse Distributing, Inc.
K933309	PRINCE	Oct 01, 1993	Substantially Equivalent	Goldsmith & Revere, Inc.
K922100	DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE	Mar 15, 1993	Substantially Equivalent	Graham Medical Products
K923640	GK DENTAL AMALGAM ALLOY	Feb 12, 1993	Substantially Equivalent	The Patron Trading Corp.
K923384	ANA 70 DISPERSED PHASE DENTAL ALLOY -- MODIFIED	Jan 11, 1993	Substantially Equivalent	L.C. Dental
K921538	AMALGAPHASE	Aug 10, 1992	Substantially Equivalent	Saskan Amalgam Alloys, Inc.
K915654	KERALLOY-D CAPS	Mar 02, 1992	Substantially Equivalent	Wilde-USA, Inc.
K913175	MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES	Dec 27, 1991	Substantially Equivalent	G-C Intl. Corp.
K912992	KERALLOY NON-GAMMA 2 AMALGAM	Nov 13, 1991	Substantially Equivalent	Wilde-USA, Inc.
K905204	DW 236	Mar 29, 1991	Substantially Equivalent	Ivoclar North America, Inc.
K905205	DW 235	Dec 17, 1990	Substantially Equivalent	Ivoclar North America, Inc.
K902249	LUXALLOY 50 (POWDER, TABLETS, PREDOSED CAPSULES)	Jul 13, 1990	Substantially Equivalent	Degussa AG
K902248	LUXALLOY CAPS (PREDOSED CAPSULES)	Jul 13, 1990	Substantially Equivalent	Degussa AG
K902247	ARTALLOY (POWDER)	Jul 13, 1990	Substantially Equivalent	Degussa AG
K901911	VIVAALLOY HR (AMALGAM)	Jun 01, 1990	Substantially Equivalent	Ivoclar North America, Inc.
K901256	AMALCAP PLUS	Apr 27, 1990	Substantially Equivalent	Ivoclar North America, Inc.
K890662	PENT CAPS	May 09, 1989	Substantially Equivalent	Jeneric/Pentron, Inc.
K890682	OROSPHERE PLUS	May 05, 1989	Substantially Equivalent	Jeneric/Pentron, Inc.
K890681	OROSPHERE HCDP	May 02, 1989	Substantially Equivalent	Jeneric/Pentron, Inc.
K891390	GK ALLOY	Apr 17, 1989	Substantially Equivalent	China Link, Inc.
K881333	OLYMPIA ALLOY	Apr 21, 1988	Substantially Equivalent	J.F. Jelenko & Co., Inc.
K875344	HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY	Mar 18, 1988	Substantially Equivalent	Kulzer, Inc.
K870230	ALLOY FOR DENTAL AMALGAM LUXALLOY NON GAMMA 2	May 20, 1987	Substantially Equivalent	Degussa Dental, Inc.
K844653	LIMI ALLOY	Mar 25, 1985	Substantially Equivalent	G-C Intl. Corp.
K840297	COLTENE ORALLOY MAGICAPS	Mar 16, 1984	Substantially Equivalent	Coltene, Inc.
K823098	REX-CAPS	Nov 10, 1982	Substantially Equivalent	Bauer, Cheng & Associates, Inc.
K822951	SPHEREX E.C.T.	Oct 26, 1982	Substantially Equivalent	Jeneric Ind.
K821971	VALULINE* AMALGAM ALLOY	Jul 20, 1982	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K821226	DENTAL AMALGAM ALLOY	Jun 07, 1982	Substantially Equivalent	Dental Alloyers Intl., Inc.
K821222	GOLDSMITH & REVERE TENARY ALLOY	May 24, 1982	Substantially Equivalent	Goldsmith & Revere, Inc.
K820738	LUSTRALLOY	Apr 09, 1982	Substantially Equivalent	Hoyt Laboratories
K820617	DISPERSED PHASE ALLOY	Mar 25, 1982	Substantially Equivalent	Goldsmith & Revere, Inc.
K820389	A DENTAL AMALGAM ALLOY (UNNAMED	Mar 11, 1982	Substantially Equivalent	Dentsply Intl.
K820181	SYBRON/KERR CONTOUR	Feb 24, 1982	Substantially Equivalent	Sybron Corp.
K812827	ORBIC* SPHERICAL ALLOY	Nov 16, 1981	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K810907	COLTENE ORALLY	Apr 23, 1981	Substantially Equivalent	Coltene, Inc.
K801639	PERMITE DENTAL AMALGAM ALLOY	Aug 27, 1980	Substantially Equivalent	Southern Dental Industries, Inc.
K801690	VALIANT	Aug 13, 1980	Substantially Equivalent	L.D. Caulk Co.
K790874	AMALCAP-NON-GAMMA-2	Jun 05, 1979	Substantially Equivalent	Vivadent (Usa), Inc.
K790448	EASYFIL	Apr 11, 1979	Substantially Equivalent	General Refineries, Inc.
K781242	ALLOY, AMALGAM, DISP. CAPSULE	Aug 21, 1978	Substantially Equivalent	Lee Pharmaceuticals
K780997	AMALGAM ALLOY	Jul 27, 1978	Substantially Equivalent	Syntex Corp.
K780967	LEE-ALLOY	Jun 22, 1978	Substantially Equivalent	Lee Pharmaceuticals
K771403	EASE (MODIFICATION TO)	Aug 22, 1977	Substantially Equivalent	L.D. Caulk Co.
K771383	ALLOY DISPOS-A-CAP DENTAL SCHOOL CAP	Aug 03, 1977	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K760980	DENTAL ALLOY	Nov 15, 1976	Substantially Equivalent	Adp Intl., Inc.