FDA 510(k) Applications for Medical Device Product Code "EJT"
(Alloy, Gold-Based Noble Metal)

FDA 510(k) Number Applicant Device Name Decision Date
K972532 AALBA DENT, INC. AALBA GOLD SOLDER 08/15/1997
K972632 AALBA DENT, INC. VERA PD SOLDER 08/15/1997
K961352 ARGEN PRECIOUS METALS, INC. 285 SL 05/20/1996
K961285 ARGEN PRECIOUS METALS, INC. ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION) 04/18/1996
K961211 ARGEN PRECIOUS METALS, INC. ARGELITE 52+ 04/25/1996
K972952 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD AUREBOND 51 09/05/1997
K972938 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD AURECAST 10 08/25/1997
K972936 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD AURECAST 2 08/25/1997
K972937 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD AURECAST 4 08/25/1997
K972941 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD AURECAST 74 08/28/1997
K972942 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD AURECAST 83 08/28/1997
K972943 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD AURECAST 92 09/16/1997
K972939 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD AURECAST BIO 59PF 08/26/1997
K972940 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD AURECAST BIO 69PF 08/26/1997
K972319 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD AURECAST GF 08/26/1997
K972946 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD AURELUX 77 12/19/1997
K972949 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD AURELUX BIO Y85PF 09/18/1997
K972950 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD HIPALLAUR 19 09/05/1997
K972951 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD HIPALLAUR 51 09/05/1997
K972953 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD PALAUREX 76KF 09/05/1997
K972954 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD PALAUREX 78 09/05/1997
K972955 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD PALCERAM 56 09/05/1997
K972956 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD PALCERAM 82SF 09/05/1997
K001480 AUREX SA (PTY) LTD. AURECAST 40 B 06/21/2000
K001478 AUREX SA (PTY) LTD. AURECAST SUPER INLAY 06/20/2000
K001477 AUREX SA (PTY) LTD. AURELUX Y 84 PREMIUM 06/20/2000
K001482 AUREX SA (PTY) LTD. AURENORM 75 KF 06/23/2000
K001481 AUREX SA (PTY) LTD. PALCERAM 49 06/23/2000
K001479 AUREX SA (PTY) LTD. PALCERAM 53 06/21/2000
K983080 BEGO U.S.A. AUROLLOYD KF 10/28/1998
K983082 BEGO U.S.A. BEGOCER G 10/28/1998
K983077 BEGO U.S.A. BIO PONTOSTAR 10/23/1998
K033279 BEGO U.S.A. GOLD DENTAL CASTING ALLOYS 01/15/2004
K983079 BEGO U.S.A. PLATINLLOYD 100 10/23/1998
K990670 C. HAFNER GMBH & CO. HELIOFORM GOLD-BASED ALLOY 04/02/1999
K960104 DEGUSSA CORP. BIOCCLUS 4 02/06/1996
K960256 DEGUSSA CORP. DEGUDENT LS 02/21/1996
K960226 DEGUSSA CORP. DG 88 02/14/1996
K972910 DEGUSSA CORP. PORS ON LITE 10/14/1997
K032320 DENTSPLY INTERNATIONAL APPOLLO 3 ALLOY 10/01/2003
K032321 DENTSPLY INTERNATIONAL CERA F ALLOY 09/30/2003
K032319 DENTSPLY INTERNATIONAL CERA R PLUS ALLOY 09/30/2003
K032318 DENTSPLY INTERNATIONAL MINERVA 58 ALLOY 09/30/2003
K032851 DENTSPLY INTERNATIONAL ULTRACROWN 75 ALLOY 09/26/2003
K032316 DENTSPLY INTL. ORION E ALLOY 09/30/2003
K032317 DENTSPLY INTL. ORION GX ALLOY 09/30/2003
K980660 EUROPEAN DENTAL IMPORTS, INC. BIOGOLD PLUS DENTAL ALLOY 04/27/1998
K980597 EUROPEAN DENTAL IMPORTS, INC. CARRARA PDF, CARRARA H, CARRARA R 03/09/1998
K964948 GATEWAY ALLOYS, INC. AURORA 52 (PM-01) 01/13/1997
K964949 GATEWAY ALLOYS, INC. AURORA 53 01/13/1997
K011626 GATEWAY ALLOYS, INC. CONCORD 72 07/16/2001
K011628 GATEWAY ALLOYS, INC. CONCORD 82 07/16/2001
K011661 GATEWAY ALLOYS, INC. CONCORD 88 08/27/2001
K964476 GATEWAY ALLOYS, INC. DE ORO 77 12/04/1996
K964941 GATEWAY ALLOYS, INC. EL DORADO 40 01/13/1997
K964788 GATEWAY ALLOYS, INC. EL DORADO 55 12/20/1996
K964569 GATEWAY ALLOYS, INC. EL DORADO 58 12/06/1996
K964567 GATEWAY ALLOYS, INC. EL DORADO 75 12/06/1996
K011659 GATEWAY ALLOYS, INC. GPW-SF 08/27/2001
K964950 GATEWAY ALLOYS, INC. LA PLATA 28 (PM-28) 01/13/1997
K964465 GATEWAY ALLOYS, INC. LA PLATA 34 (PM-25) 11/26/1996
K964789 GATEWAY ALLOYS, INC. LA PLATA 39 12/20/1996
K964792 GATEWAY ALLOYS, INC. LA PLATA 40 12/20/1996
K964478 GATEWAY ALLOYS, INC. OSAGE 76 11/26/1996
K964566 GATEWAY ALLOYS, INC. OZARK 20 12/06/1996
K964477 GATEWAY ALLOYS, INC. OZARK 40 12/02/1996
K964568 GATEWAY ALLOYS, INC. OZARK 46 12/06/1996
K964464 GATEWAY ALLOYS, INC. PACIFIC 52 (CB-39) 11/26/1996
K964837 GATEWAY ALLOYS, INC. PACIFIC 56 (CB-40) 12/20/1996
K964466 GATEWAY ALLOYS, INC. PALLADIA 75 (PM-11) 11/20/1996
K964572 GATEWAY ALLOYS, INC. PALLADIA 76 12/06/1996
K964838 GATEWAY ALLOYS, INC. PALLADIA 85 (PM-13) 12/20/1996
K964573 GATEWAY ALLOYS, INC. PIEDMONT 70 (CH-35) 12/06/1996
K964708 GATEWAY ALLOYS, INC. SOLDER 615 12/16/1996
K964940 GATEWAY ALLOYS, INC. TAOS 28 01/13/1997
K034049 HERAEUS KULZER GMBH HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM 03/01/2004
K040043 HERAEUS KULZER, INC. NDX-40 ALLOY 03/03/2004
K011036 HERAEUS KULZER, INC. RD-3008 05/10/2001
K964772 IVOCLAR NORTH AMERICA, INC. AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS) 01/17/1997
K011022 IVOCLAR NORTH AMERICA, INC. BIOUNIVERSAL PDF 05/02/2001
K011023 IVOCLAR NORTH AMERICA, INC. D.SIGN 96 05/02/2001
K003634 IVOCLAR NORTH AMERICA, INC. DW 272 #1 12/21/2000
K003635 IVOCLAR NORTH AMERICA, INC. DW 276 #3 12/22/2000
K003633 IVOCLAR NORTH AMERICA, INC. DW 277 #4 12/20/2000
K002872 IVOCLAR NORTH AMERICA, INC. R&D PROJECT DW271#11A 11/02/2000
K970963 IVOCLAR NORTH AMERICA, INC. TARGIS ALLOY #7 04/30/1997
K012877 IVOCLAR USA, INC. HIGH GOLD PALLADIUM FREE CERAMIC SOLDER 11/21/2001
K032493 IVOCLAR VIVADENT, INC. ALEXANDER 09/04/2003
K030436 IVOCLAR VIVADENT, INC. BIO UNIVERSAL 04/15/2003
K030435 IVOCLAR VIVADENT, INC. BIOUNIVERSAL PKF 04/15/2003
K021892 IVOCLAR VIVADENT, INC. BRIGHT GOLD 07/25/2002
K032715 IVOCLAR VIVADENT, INC. DW 296 #15 SOLDER 09/26/2003
K022969 IVOCLAR VIVADENT, INC. UNIVERSAL CERAMIC SOLDER 10/18/2002
K022811 IVOCLAR VIVADENT, INC. W-5 10/09/2002
K001260 J.F. JELENKO & CO., INC. ALLROUND 55 LF 05/17/2000
K971575 J.F. JELENKO & CO., INC. BENCHMARK-IV 06/04/1997
K981244 J.F. JELENKO & CO., INC. BW-1 (CODE NAME RD-0807) 08/13/1998
K960403 J.F. JELENKO & CO., INC. DIAMOND (CODE NAME PT-054) 02/26/1996
K993136 J.F. JELENKO & CO., INC. JEL BIOS 10 (CODE NAME RD-1801) 10/21/1999
K993152 J.F. JELENKO & CO., INC. JEL BIOS 18 (CODE NAME RD- 1214) 10/21/1999
K001196 J.F. JELENKO & CO., INC. JEL BIOS 90 (CODE NAME RD-2401) 05/11/2000
K002645 J.F. JELENKO & CO., INC. JEL BIOS PURE 10/19/2000
K971292 J.F. JELENKO & CO., INC. JEL-71 PDF 05/20/1997
K971574 J.F. JELENKO & CO., INC. JELBOND-PDF 05/20/1997
K970068 J.F. JELENKO & CO., INC. JELENKO NO.1 (CODE NAME RD-0601) 03/24/1997
K984140 J.F. JELENKO & CO., INC. MAINBOND A 01/13/1999
K973881 J.F. JELENKO & CO., INC. PROSPECTOR PLUS (CODE NAME : RD-0508) 11/24/1997
K002222 J.F. JELENKO & CO., INC. RD-2104 08/31/2000
K960399 J.F. JELENKO & CO., INC. TOPAZ 02/21/1996
K003603 JELENKO CO. BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE 01/10/2001
K010416 JELENKO CO. HERACERAM 75 03/08/2001
K964158 JELENKO CO. JEL-40 (CODE NAME RD-0430) 12/13/1996
K991901 JENERIC/PENTRON, INC. BIO-97 09/07/1999
K010044 JENERIC/PENTRON, INC. COSMIC 02/09/2001
K993173 JENERIC/PENTRON, INC. GOLD CORE 55 10/26/1999
K011362 JENERIC/PENTRON, INC. GOLD CORE 73 LS 05/29/2001
K993175 JENERIC/PENTRON, INC. GOLD CORE 75 10/26/1999
K002815 JENERIC/PENTRON, INC. GOLD CORE HF PRE SOLDER 12/19/2000
K002854 JENERIC/PENTRON, INC. GOLD CORE POST SOLDER 12/20/2000
K011331 JENERIC/PENTRON, INC. JP CAST 40 06/22/2001
K011330 JENERIC/PENTRON, INC. JP CAST 50 06/22/2001
K001051 JENERIC/PENTRON, INC. RX EVEREST 04/28/2000
K000360 JENERIC/PENTRON, INC. RX G-UNIVERSAL 02/18/2000
K002826 JENSEN INDUSTRIES, INC. EQUITY 10/24/2000
K022206 JENSEN INDUSTRIES, INC. JENSEN GOLD FOIL 08/29/2002
K010414 JENSEN INDUSTRIES, INC. R & D DESIGNATION AP-035 03/27/2001
K010611 JENSEN INDUSTRIES, INC. R & D DESIGNATION AP-047 03/27/2001
K032267 JENSEN INDUSTRIES, INC. R&D DESIGNATION AP-052-5 09/17/2003
K041378 KODENT, INC. BIO 60 08/02/2004
K021947 LUCIUS METALS COM. CERANUM 87 08/26/2002
K021948 LUCIUS METALS COM. LUCIUS 62 09/03/2002
K973372 METALOR DENTAL USA CORP. AUROFILM 2000 11/26/1997
K982606 METALOR DENTAL USA CORP. AUROFLUID CPF 10/15/1998
K993508 METALOR DENTAL USA CORP. V-SUPRA PLUS, ALLOY NO. 5025 12/06/1999
K993507 METALOR DENTAL USA CORP. V-SUPRAGOLD, ALLOY NO. 5024 12/06/1999
K013505 METALOR TECHNOLOGIES USA AUROFLUID PLUS 12/19/2001
K013769 METALOR TECHNOLOGIES USA V-GNATHOS SUPRA 01/22/2002
K013506 METALOR TECHNOLOGIES USA YELLOW SPECIAL 01/03/2002
K980613 MICRO DENTAL LABORATORIES PROGOLD ELECTROCOPING SYSTEM 03/09/1998
K023501 PENTRON LABORATORY TECHNOLOGIES GOLD CORE 35 12/18/2002
K023790 PRECIOUS CHEMICALS U.S.A., INC. UCC DENTAL MATERIAL 01/21/2003
K023831 PRECIOUS CHEMICALS U.S.A., INC. UCP DENTAL MATERIAL 01/24/2003
K002675 PRODUCT DEVELOPMENT INDUSTRIES, INC. MILLENNIUM EDITION 2000 ACCELERATED ELECTROFORMING SYSTEM 10/25/2000
K052463 PROMETAL TECHNOLOGIES PROMETAL HN86 10/14/2005
K024140 SB LUCIUS, INC. AIGIS-A 03/06/2003
K024143 SB LUCIUS, INC. AIGIS-FINE 03/10/2003
K024139 SB LUCIUS, INC. AIGIS-INLAY 03/07/2003
K024135 SB LUCIUS, INC. AIGIS-PLUS 03/10/2003
K024144 SB LUCIUS, INC. AIGIS-PT 03/07/2003
K024136 SB LUCIUS, INC. AIGIS-SOFT 03/10/2003
K024142 SB LUCIUS, INC. AIGIS-SUPER 03/10/2003
K024145 SB LUCIUS, INC. AIGIS-XO 03/07/2003
K023199 SB LUCIUS, INC. CERANUM 50 11/04/2002
K023200 SB LUCIUS, INC. CERANUM 76 11/04/2002
K023197 SB LUCIUS, INC. CERANUM 82 11/05/2002
K023198 SB LUCIUS, INC. CERANUM 90 11/01/2002
K023196 SB LUCIUS, INC. LUCIUS 76 11/01/2002
K031010 SB LUCIUS, INC. MIRACLE 98 06/25/2003
K024141 SB LUCIUS, INC. NEO 76 03/06/2003
K032106 STAR REFINING PRECIOUS METALS SOUTH AFRICA STARBOND DENTAL BONDING ALLOYS 08/25/2003
K031543 STAR REFINING PRECIOUS METALS SOUTH AFRICA STARCAST DENTAL ALLOYS 05/30/2003
K020949 STERNGOLD APOLLO, MODEL 1124525 04/04/2002
K021741 STERNGOLD CRITERTION, MODEL #1067511 06/26/2002
K003007 STERNGOLD GALAXY 11/17/2000
K962302 STERNGOLD/IMPLAMED PEGASUS DENTAL ALLOY 07/18/1996
K962325 STERNGOLD/IMPLAMED QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015) 07/24/1996
K962326 STERNGOLD/IMPLAMED STERNGOLD BIO-5 (1127210) 07/24/1996
K962303 STERNGOLD/IMPLAMED STERNGOLD CF 07/18/1996
K960956 STERNGOLD/IMPLAMED STERNGOLD M-PF YELLOW CROWN & BRIDGE ALLOY MODEL 1127200 05/29/1996
K030206 WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD. APEX 90 01/29/2003
K033446 WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD. APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 11/13/2003
K033435 WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD. E-SARANG 86, DM78, DM55 11/12/2003
K023392 WIELAND DENTAL + TECHNIK GMBH & CO. KG AGC SPECIAL ALLOY 12/06/2002
K021926 WIELAND DENTAL + TECHNIK GMBH & CO. KG AUROPAL 60 07/25/2002
K022459 WIELAND DENTAL + TECHNIK GMBH & CO. KG AUROPAL SOLDER M-1 09/12/2002
K022451 WIELAND DENTAL + TECHNIK GMBH & CO. KG AUROPAL SOLDER W-2 09/11/2002
K021733 WIELAND DENTAL + TECHNIK GMBH & CO. KG AUTOPAL 50 06/26/2002
K023391 WIELAND DENTAL + TECHNIK GMBH & CO. KG BIOPORTA G 12/10/2002
K022462 WIELAND DENTAL + TECHNIK GMBH & CO. KG BIOPORTA SOLDER 1020 09/18/2002
K022663 WIELAND DENTAL + TECHNIK GMBH & CO. KG KERADEC 10/31/2002
K023389 WIELAND DENTAL + TECHNIK GMBH & CO. KG PORTA GEO TI 12/06/2002
K030312 WIELAND DENTAL + TECHNIK GMBH & CO. KG PORTA IMPLANT 03/26/2003
K022456 WIELAND DENTAL + TECHNIK GMBH & CO. KG PORTA IP SOLDER V-1 09/17/2002
K022467 WIELAND DENTAL + TECHNIK GMBH & CO. KG PORTA IP SOLDER V-2 09/17/2002
K022452 WIELAND DENTAL + TECHNIK GMBH & CO. KG PORTA OP SOLDER M-1 09/11/2002
K022454 WIELAND DENTAL + TECHNIK GMBH & CO. KG PORTA OP SOLDER W-2 09/12/2002
K022457 WIELAND DENTAL + TECHNIK GMBH & CO. KG PORTA OPTIMUM SOLDER 710 09/17/2002
K022468 WIELAND DENTAL + TECHNIK GMBH & CO. KG PORTA OPTIMUM SOLDER 900 09/17/2002
K031264 WIELAND DENTAL + TECHNIK GMBH & CO. KG PORTA PRESSOVER 06/12/2003
K040672 WIELAND DENTAL + TECHNIK GMBH & CO. KG PORTA REFLEX 05/27/2004
K022470 WIELAND DENTAL + TECHNIK GMBH & CO. KG PORTA SOLDER 1080 W 09/18/2002
K040524 WIELAND DENTAL + TECHNIK GMBH & CO. KG PORTA SOLDER 1090 W 05/20/2004
K020190 WIELAND DENTAL + TECHNIK GMBH & CO. KG PORTADUR P 4 03/13/2002
K023395 WIELAND DENTAL + TECHNIK GMBH & CO. KG PORTADUR P2 12/11/2002
K021242 WIELAND DENTAL + TECHNIK GMBH & CO. KG PORTALLOY 54 05/16/2002
K020347 WIELAND EDELMETALLE GMBH & CO. AGC SPEZIALLEGIERUNG 04/24/2002
K001041 WIELAND EDELMETALLE GMBH & CO. AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD 05/23/2000
K012839 WIELAND EDELMETALLE GMBH & CO. AUROPAL, ORDER-NO.: 2101 12/31/2001
K012831 WIELAND EDELMETALLE GMBH & CO. BIO PORTADUR, ORDER-NO.:2017 11/01/2001
K012826 WIELAND EDELMETALLE GMBH & CO. BIOPORTA G, MODEL 2052 11/01/2001
K012838 WIELAND EDELMETALLE GMBH & CO. ERO50, ORDER-NO.: 2070 10/23/2001
K012827 WIELAND EDELMETALLE GMBH & CO. PORTA AURIUM, MODEL 2067 11/01/2001
K012834 WIELAND EDELMETALLE GMBH & CO. PORTA GEO TI MODEL #2004 11/01/2001
K012835 WIELAND EDELMETALLE GMBH & CO. PORTA MAXIMUM, MODEL# 2066 11/01/2001
K012843 WIELAND EDELMETALLE GMBH & CO. PORTADUR P 2, MODEL #2031 11/02/2001


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