Product Code: EJH FDA class 2 21 CFR 872.3710

Alloy, Metal, Base

Dental

The Base Metal Alloy is a dental casting material composed primarily of non-precious metals such as nickel, chromium, cobalt, or beryllium alloys, used in the fabrication of metal copings, crowns, bridges, and removable partial denture frameworks. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance. The product code is EJH, regulated under 21 CFR 872.3710 in the Dental (DE) specialty.

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510(k)s

153

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: EJH
Device Class: FDA class 2
Regulation Number: 872.3710
Medical Specialty: Dental
Review Panel: DE
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 153 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K123929	BEGOPAL+	Mar 14, 2013	Substantially Equivalent	Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO
K040180	CONTINUM V	Mar 04, 2004	Substantially Equivalent	Aalba Dent, Inc.
K040179	CONTINUM	Mar 03, 2004	Substantially Equivalent	Aalba Dent, Inc.
K033356	VERASOFT ES	Dec 30, 2003	Substantially Equivalent	Aalba Dent, Inc.
K033045	DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST	Dec 23, 2003	Substantially Equivalent	American Green Dent. Mfg, Inc.
K032136	WIROBOND C	Sep 04, 2003	Substantially Equivalent	Bego U.S.A.
K031627	NANO-TICROWN	Jun 11, 2003	Substantially Equivalent	Nano-Write Corp.
K030632	PD CASTA-H	May 07, 2003	Substantially Equivalent	Mountain Medico, Inc.
K030416	CERACAST-V	Apr 14, 2003	Substantially Equivalent	Mountain Medico, Inc.
K030161	SUPERBOND	Mar 17, 2003	Substantially Equivalent	American Dent-All, Inc.
K024214	KAVO EVEREST TITANBLANK	Mar 12, 2003	Substantially Equivalent	Kavo America
K023499	GOLD CORE PLUS	Jan 13, 2003	Substantially Equivalent	Pentron Laboratory Technologies
K023502	JEWEL CAST PLUS	Dec 18, 2002	Substantially Equivalent	Pentron Laboratory Technologies
K023477	BIOLOY	Dec 13, 2002	Substantially Equivalent	Neirynck & Vogt NV
K021971	CERALOY	Aug 01, 2002	Substantially Equivalent	Neirynck & Vogt NV
K021969	CHROLOY	Jul 30, 2002	Substantially Equivalent	Neirynck & Vogt NV
K021968	CERALOY SOLDER	Jul 26, 2002	Substantially Equivalent	Neirynck & Vogt NV
K021965	CHROLOY SOLDER	Jul 26, 2002	Substantially Equivalent	Neirynck & Vogt NV
K020253	4 ALL (DW286A)	Apr 17, 2002	Substantially Equivalent	Ivoclar Vivadent, Inc.
K020898	D.SIGN 15 (DW286 B)	Mar 29, 2002	Substantially Equivalent	Ivoclar Vivadent, Inc.
K020183	PISCES PLUS (DW286 C)	Mar 13, 2002	Substantially Equivalent	Ivoclar Vivadent, Inc.
K020062	XERAFIT	Feb 14, 2002	Substantially Equivalent	Metalor Technologies USA
K011706	FLEXICAST PRIME	Aug 06, 2001	Substantially Equivalent	American Dent-All, Inc.
K011705	SUPREMCAST	Aug 03, 2001	Substantially Equivalent	American Dent-All, Inc.
K010381	D.SIGN 30	Mar 06, 2001	Substantially Equivalent	Ivoclar North America, Inc.
K010069	DURABOND NON-PRECIOUS CERAMIC ALLOY	Feb 15, 2001	Substantially Equivalent	Matech, Inc.
K003387	AUROFILM NP	Jan 09, 2001	Substantially Equivalent	Metalor Dental USA Corp.
K003509	FLEXICAST	Jan 02, 2001	Substantially Equivalent	American Dent-All, Inc.
K003039	GOLD CORE II	Dec 05, 2000	Substantially Equivalent	Jeneric/Pentron, Inc.
K003037	JEWEL CAST III	Dec 05, 2000	Substantially Equivalent	Jeneric/Pentron, Inc.
K002302	SUPER 14	Sep 26, 2000	Substantially Equivalent	Dental Alloy Products, Inc.
K002300	SUPER 6	Sep 26, 2000	Substantially Equivalent	Dental Alloy Products, Inc.
K002301	SUPER 12	Sep 08, 2000	Substantially Equivalent	Dental Alloy Products, Inc.
K002299	SUPER 3	Sep 08, 2000	Substantially Equivalent	Dental Alloy Products, Inc.
K002298	SUPER 1	Aug 24, 2000	Substantially Equivalent	Dental Alloy Products, Inc.
K001798	DC TITAN	Jul 31, 2000	Substantially Equivalent	Austenal, Inc.
K001383	SUPREMCAST V	Jul 05, 2000	Substantially Equivalent	American Dent-All, Inc.
K001269	DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC	Jun 21, 2000	Substantially Equivalent	Dentalmatic Technologies, Inc.
K000981	CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX	Jun 13, 2000	Substantially Equivalent	C-Mix
K993572	CERADIUM V NON-PRECIOUS CERAMIC ALLOY	Dec 13, 1999	Substantially Equivalent	Matech, Inc.
K992881	HI BOND NON-PRECIOUS CERAMIC ALLOY	Nov 19, 1999	Substantially Equivalent	Matech, Inc.
K993344	P10 SPECIAL	Nov 15, 1999	Substantially Equivalent	North American Alloys, Inc.
K992705	CERADIUM NON-PRECIOUS CERAMIC ALLOY	Sep 22, 1999	Substantially Equivalent	Matech, Inc.
K990235	D-SIGN VI (R&D PROJECT DW266#9)	Mar 01, 1999	Substantially Equivalent	Ivoclar North America, Inc.
K990182	D-SIGN V (R&D PROJECT DW267#17)	Mar 01, 1999	Substantially Equivalent	Ivoclar North America, Inc.
K984164	JELBOND NP	Dec 29, 1998	Substantially Equivalent	Jelenko Co.
K982094	VERABOND 2	Jul 22, 1998	Substantially Equivalent	Aalba Dent, Inc.
K972971	NPG + 2	Jan 05, 1998	Substantially Equivalent	Aalba Dent, Inc.
K973569	SOWELL NICKEL-CHROME-MOLYBDENUM ALLOY	Dec 11, 1997	Substantially Equivalent	C.K. International Trading
K973568	SOWELL NICKEL-CHROME NON-PRECIOUS METAL ALLOY	Dec 11, 1997	Substantially Equivalent	C.K. International Trading
K973567	SOWELL COBALT-CHROME METAL ALLOY	Dec 11, 1997	Substantially Equivalent	C.K. International Trading
K973566	SOWELL PATENTED NON-PRECIOUS METAL ALLOY	Dec 08, 1997	Substantially Equivalent	C.K. International Trading
K973265	VERABOND 2V	Oct 16, 1997	Substantially Equivalent	Aalba Dent, Inc.
K972607	PLATALLOY	Oct 10, 1997	Substantially Equivalent	Aalba Dent, Inc.
K972118	VERA PDN	Aug 15, 1997	Substantially Equivalent	Aalba Dent, Inc.
K970205	VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY	Apr 21, 1997	Substantially Equivalent	Austenal, Inc.
K970827	PRECISE	Apr 16, 1997	Substantially Equivalent	Allan Schulman,D.D.S., M.S.
K963891	RX 96E	Nov 19, 1996	Substantially Equivalent	Jeneric/Pentron, Inc.
K961720	CERAMCO CROWNS AND BRIDGES	Jul 18, 1996	Substantially Equivalent	Eric S. Small, Dds
K953594	VULCAN	Sep 05, 1995	Substantially Equivalent	Cmp Industries, LLC
K952870	REMANIUM: CS & G-SOFT	Jul 27, 1995	Substantially Equivalent	Dentauraum, Inc.
K952867	REMANIUM:GM 700, GM 380, GM 800, GFH	Jul 27, 1995	Substantially Equivalent	Dentauraum, Inc.
K952866	REMATITAN TITANIUM	Jul 27, 1995	Substantially Equivalent	Dentauraum, Inc.
K952865	REMANIUM: 200,CS, 380, AND CD	Jul 26, 1995	Substantially Equivalent	Dentauraum, Inc.
K950894	SUREFIRE PF+ (HIGH PALLADIUM DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS)	Mar 31, 1995	Substantially Equivalent	Argen Precious Metals, Inc.
K950951	NEOCAST C, V, S	Mar 23, 1995	Substantially Equivalent	Neodontics, Inc.
K945714	VERABOND III	Dec 29, 1994	Substantially Equivalent	Aalba Dent, Inc.
K945713	VERABOND II	Dec 29, 1994	Substantially Equivalent	Aalba Dent, Inc.
K945712	VERABOND V	Dec 29, 1994	Substantially Equivalent	Aalba Dent, Inc.
K926165	CERAMCO CROWNS AND BRIDGES	Mar 31, 1994	Substantially Equivalent	Asap Dental Lab, Ltd.
K940749	LPG 5/10, LPG 10/5, LPG 10/15 AND LPG 15/10	Mar 28, 1994	Substantially Equivalent	Aalba Dent, Inc.
K932893	VIDENT 500 ALLOY AND VIDENT 550 BE ALLOY	Mar 28, 1994	Substantially Equivalent	Vident
K934758	R2+	Feb 18, 1994	Substantially Equivalent	Jeneric/Pentron, Inc.
K935972	ARGELOY N.P. (V) (NON-PRECIOUS DENTAL ALLOY FOR PROCELAIN APPLICATION)	Jan 26, 1994	Substantially Equivalent	Argen Precious Metals, Inc.
K935829	ARGELOY PARTIAL (NON-PRECIOUS)	Jan 26, 1994	Substantially Equivalent	Argen Precious Metals, Inc.
K924716	NICO DENTAL ALLOY	Jan 21, 1994	Substantially Equivalent	Co-Nick Alloys (India) , Ltd.
K934768	ARGELITE 81SF+	Dec 10, 1993	Substantially Equivalent	Argen Precious Metals, Inc.
K922954	R1, R2, AND R1+	Jul 22, 1993	Substantially Equivalent	Jeneric/Pentron, Inc.
K926347	DUCERANIUM U	May 27, 1993	Substantially Equivalent	Degussa AG
K925579	VERASOFT CASTING ALLOY	Mar 16, 1993	Substantially Equivalent	Aalba Dent, Inc.
K922790	DEGUCAST 40	Dec 03, 1992	Substantially Equivalent	Degussa AG
K915250	WIL-PDS & WIL-PDI CASTING ALLOYS	Apr 21, 1992	Substantially Equivalent	Wilde-USA, Inc.
K920561	DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET.	Mar 02, 1992	Substantially Equivalent	Ivoclar North America, Inc.
K915249	VERA PDS & VERA PDI	Mar 02, 1992	Substantially Equivalent	Aalba Dent, Inc.
K915248	LPG CASTING ALLOY	Dec 30, 1991	Substantially Equivalent	Aalba Dent, Inc.
K915247	NPG III CASTING ALLOY	Dec 30, 1991	Substantially Equivalent	Aalba Dent, Inc.
K913857	ROCATEC(R) -PLUS	Dec 16, 1991	Substantially Equivalent	Espe GmbH (Us)
K911323	FLUX-N-ALL	Sep 30, 1991	Substantially Equivalent	Precident Corp.
K905034	HD-4 CROWN & BRIDGE ALLOY	Sep 05, 1991	Substantially Equivalent	Ho Dental Co., Inc.
K901552	(CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE	Jun 24, 1991	Substantially Equivalent	Nobelpharma USA, Inc.
K911821	THERMABOND SUPERCAST NP OR THERMABOND SUPERCAST	May 30, 1991	Substantially Equivalent	Dentecon, Inc.
K903538	WIRON 99 DENTAL CASTING ALLOY	Mar 15, 1991	Substantially Equivalent	Leach and Dillon Co., Inc.
K903008	VIDENT 90 ALLOY AND VIDENT 95 ALLOY	Sep 06, 1990	Substantially Equivalent	Vident
K900117	STELLITE COBALT/CHROMIUM BASE METAL ALLOY	Apr 02, 1990	Substantially Equivalent	D.C. Dental Specialties
K896501	TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS)	Feb 09, 1990	Substantially Equivalent	Leach and Dillon Co., Inc.
K894085	TALLADIUM TILITE CERAMIC ALLOY	Dec 20, 1989	Substantially Equivalent	Talladium, Inc.
K884257	LEVINIUM	Dec 22, 1988	Substantially Equivalent	Ticomet Engineering & Consulting
K882170	RX ASPEN	Jun 17, 1988	Substantially Equivalent	Jeneric/Pentron, Inc.
K880875	VITALLIUM EQUIPOISE ALLOY	Apr 07, 1988	Substantially Equivalent	Austenal Dental, Inc.
K873661	CHROME-COBALT BASE DENTAL ALLOY	Nov 16, 1987	Substantially Equivalent	North American Alloys, Inc.
K864826	A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY)	Feb 10, 1987	Substantially Equivalent	Austenal Dental, Inc.
K863782	NPG NONPRECIOUS CROWN AND BRIDGE ALLOY	Nov 07, 1986	Substantially Equivalent	Aalba Dent, Inc.
K862930	PERFECT ONE	Oct 24, 1986	Substantially Equivalent	North American Alloys, Inc.
K862822	REXILLIUM N. B. F.	Sep 02, 1986	Substantially Equivalent	Jeneric Ind.
K862499	ULTRACAST	Aug 18, 1986	Substantially Equivalent	Ultratek
K862870	RESISTAL P	Aug 15, 1986	Substantially Equivalent	Degussa Dental, Inc.
K862667	COBALT, 29.5% CHROMIUM ALLOY DENTAL BAKE-ON ALLOY	Jul 31, 1986	Substantially Equivalent	Austenal Dental, Inc.
K862417	NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOY	Jul 03, 1986	Substantially Equivalent	Austenal Dental, Inc.
K861820	BIOSIL F	Jun 13, 1986	Substantially Equivalent	Degussa Dental, Inc.
K861787	BIOSIL H	May 21, 1986	Substantially Equivalent	Degussa Dental, Inc.
K860437	PARTIAL DENTURE ALLOY	Mar 17, 1986	Substantially Equivalent	Dentsply Intl.
K860217	NCM - ALPHA ALLOY (DENTAL BAKE-ON ALLOY)	Mar 17, 1986	Substantially Equivalent	Austenal Dental, Inc.
K854738	SPARTAN SOLDER	Mar 06, 1986	Substantially Equivalent	Williams Gold Refining Co., Inc.
K854878	H40 BASE METAL ALLOY	Jan 30, 1986	Substantially Equivalent	Jeneric Ind.
K854495	GRESCO N.P. DENTAL ALLOY	Dec 27, 1985	Substantially Equivalent	Gresco Products, Inc.
K854285	GDC 1453 CASTING ALLOY	Dec 27, 1985	Substantially Equivalent	Deringer-Ney, Inc.
K853845	ALLOY B	Nov 19, 1985	Substantially Equivalent	North American Alloys, Inc.
K852895	CERAMIC ALLOY NO. DW 179	Oct 21, 1985	Substantially Equivalent	Williams Gold Refining Co., Inc.
K853498	PERFECT 10	Sep 27, 1985	Substantially Equivalent	North American Alloys, Inc.
K851515	HERAENIUM CA	Sep 23, 1985	Substantially Equivalent	Heraeus Dental Gold Corp.
K850084	TRINDIUM-DENTAL MATERIAL	Jul 08, 1985	Substantially Equivalent	Trindium Corp. of America
K851569	VERA BOND NON PERCIOUS CERAMIC ALLOY	May 29, 1985	Substantially Equivalent	Aalba Dent, Inc.
K844497	AUSTENAL A-79 CROWN & BRIDGE CASTING ALLOY	Feb 27, 1985	Substantially Equivalent	Austenal Dental, Inc.
K844123	RX CBY	Jan 09, 1985	Substantially Equivalent	Jeneric Ind.
K844122	RX CBG	Jan 09, 1985	Substantially Equivalent	Jeneric Ind.
K842551	BASE METAL ALLOY	Aug 02, 1984	Substantially Equivalent	Dentsply Intl.
K842377	MS NONPRECIOUS CROWN & BRIDGE ALLOY	Jul 31, 1984	Substantially Equivalent	Dental Ventures of America, Inc.
K841290	STELDENT - DENTAL ALLOY	Jun 27, 1984	Substantially Equivalent	Eriez
K840562	REX V	Apr 13, 1984	Substantially Equivalent	Jeneric Ind.
K834560	VITEX P.D.A	Feb 27, 1984	Substantially Equivalent	Jeneric Ind.
K833512	PARTIAL DENTURE ALLOY	Dec 27, 1983	Substantially Equivalent	Dentsply Intl.
K833143	REXILLIUM III	Dec 08, 1983	Substantially Equivalent	Jeneric Ind.
K833145	ZENITH	Nov 28, 1983	Substantially Equivalent	Jeneric Ind.
K833144	REX ALLOY	Oct 28, 1983	Substantially Equivalent	Jeneric Ind.
K823008	NOVAREX	Nov 03, 1982	Substantially Equivalent	Jeneric Ind.
K822957	PURCAST	Oct 26, 1982	Substantially Equivalent	J. Aderer, Inc.
K822947	NEPTUNE	Oct 26, 1982	Substantially Equivalent	Jeneric Ind.
K822948	RX BIOCAST	Oct 22, 1982	Substantially Equivalent	Jeneric Ind.
K822896	CAVIDRY	Oct 22, 1982	Substantially Equivalent	Parker Laboratories, Inc.
K820328	NICKEL-BASED DENTAL CASTING ALLOY	Mar 02, 1982	Substantially Equivalent	Dentsply Intl.
K820049	CERILLIUM	Feb 22, 1982	Substantially Equivalent	Jelrus Technical Products Corp.
K813243	CERAL-BASE METAL ALLOY	Dec 31, 1981	Substantially Equivalent	Sillard Products, Inc.
K811258	BASE METAL ALLOY	Jul 23, 1981	Substantially Equivalent	Dentsply Intl.
K811013	SUMMAR NON-PRECIOUS, CERAMIC ALLOY	Jun 26, 1981	Substantially Equivalent	Shofu Dental Corp.
K811407	BA-93	Jun 16, 1981	Substantially Equivalent	Deringer-Ney, Inc.
K810611	FULCAST/SUMMIT CASTING ALLOY	Mar 24, 1981	Substantially Equivalent	C.Vaupel Dental, Inc.
K810594	CRYSTALLOY-P	Mar 24, 1981	Substantially Equivalent	Shofu Dental Corp.
K810521	CO-SPAN 13.5 CASTING ALLOY	Mar 17, 1981	Substantially Equivalent	C.Vaupel Dental, Inc.
K800371	WILL CERAM LITE-CAST B	Feb 28, 1980	Substantially Equivalent	Williams Gold Refining Co., Inc.
K780642	LITECAST SOLDER	May 03, 1978	Substantially Equivalent	Williams Gold Refining Co., Inc.
K780090	DENTAL ALLOY	Mar 14, 1978	Substantially Equivalent	Krupp International, Inc.
K772256	CROWN & BRIDGE ALLOY	Jan 03, 1978	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K771081	LITECAST CERAMIC	Jun 24, 1977	Substantially Equivalent	Williams Gold Refining Co., Inc.