FDA 510(k) Applications for Medical Device Product Code "EJS"
(Alloy, Other Noble Metal)

FDA 510(k) Number Applicant Device Name Decision Date
K972534 AALBA DENT, INC. ALFALLOY 09/05/1997
K972533 AALBA DENT, INC. VERA SOLDER 09/05/1997
K915165 ARGEN PRECIOUS METALS, INC. ARGEBOND 77+ 04/21/1992
K913704 ARGEN PRECIOUS METALS, INC. ARGEBOND 80 11/13/1991
K934773 ARGEN PRECIOUS METALS, INC. ARGELITE A 12/10/1993
K903971 ARGEN PRECIOUS METALS, INC. ARGENCO 26B 12/17/1990
K903060 ARGEN PRECIOUS METALS, INC. ARGENCO 34 08/13/1990
K903009 ARGEN PRECIOUS METALS, INC. ARGENCO III 08/13/1990
K902665 ARGEN PRECIOUS METALS, INC. ARGENCO Y (TYPE III/IV DENTAL ALLOY CROWN/BRIDGE 08/07/1990
K910467 ARGEN PRECIOUS METALS, INC. ARGIPLUS 04/30/1991
K911757 ARGEN PRECIOUS METALS, INC. MAXIBOND 06/18/1991
K972945 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD AURENORM 68 11/26/1997
K862856 AUSTENAL DENTAL, INC. PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR 08/26/1986
K860964 AUSTENAL DENTAL, INC. WHITE SILVER SOLDER AND YELLOW SILVER SOLDER 03/26/1986
K823084 BAUER, CHENG & ASSOCIATES, INC. CHALLENGER 11/10/1982
K823097 BAUER, CHENG & ASSOCIATES, INC. NATURELLE 11/10/1982
K823100 BAUER, CHENG & ASSOCIATES, INC. RX 91 11/10/1982
K983081 BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO BEGOPAL 300 10/28/1998
K983078 BEGO U.S.A. BEGOPAL 10/23/1998
K791005 CHEMODENT DENTAL LABORATORY CHEMODENT CERAMIC METAL 08/10/1979
K840014 CHEMODENT METAL CO. CHEMODENT CERAMIC METAL 03/30/1984
K912493 DEGUSSA AG DEGUBOND LITE 08/20/1991
K921445 DEGUSSA AG DEGUBOND PLUS 05/26/1992
K921419 DEGUSSA AG DEVA PLUS 05/26/1992
K973288 DEGUSSA CORP. STABILOR HN 11/19/1997
K883511 DEGUSSA DENTAL, INC. ALBABOND E 10/06/1988
K864162 DEGUSSA DENTAL, INC. DEGUPAL 11/03/1986
K883510 DEGUSSA DENTAL, INC. DEGUPAL 4 09/15/1988
K833445 DEGUSSA DENTAL, INC. DEGUPLUS 2 12/26/1983
K832530 DEGUSSA DENTAL, INC. DEVA 4 09/29/1983
K883507 DEGUSSA DENTAL, INC. HERAEUS C SPECIAL 09/15/1988
K883509 DEGUSSA DENTAL, INC. HERAEUS DG 63 09/22/1988
K883512 DEGUSSA DENTAL, INC. HERAEUS WHITE 09/06/1988
K850193 DEGUSSA DENTAL, INC. PORS-ON HF-SOLDER(PORCELAIN DENTAL ALLOYS) 02/08/1985
K860299 DEGUSSA DENTAL, INC. REALOR ALLOY 03/17/1986
K790097 DEN-MAT CORP. SALIVAN & SALIVAN BROWN 02/26/1979
K790096 DEN-MAT CORP. SALIVAN PARAEIGHT TOUGHNESS 02/26/1979
K873373 DENPAC CORP. SINTERLOY 10/27/1987
K801009 DENTAL LABORATORY PRODUCTS DIV. HOWMEDICA WHITE C&B ALLOY 06/04/1980
K760783 DENTSPLY INTL. BIOBOND-CROWN & BRIDGE CERAMIC BONDING 10/15/1976
K913860 DENTSPLY INTL. ULTRACROWN(TM) PD ALLOY POST-SOLDER 11/13/1991
K913232 DENTSPLY INTL. ULTRACROWN(TM) PD DENTAL ALLOY 09/06/1991
K874821 DERINGER-NEY INC. "LUNAR" CASTING ALLOY FOR PORCELAIN-FUSED-TO-METAL 02/08/1988
K852347 DERINGER-NEY INC. DENTAL CASTING ALLOY GDC 1686 07/31/1985
K833596 DERINGER-NEY INC. GDC 1448 DEVELOPMENT NAME 12/29/1983
K860119 DERINGER-NEY INC. GDC 1742 (A CASTING ALLOY FOR DENTAL RESTORATIONS) 03/17/1986
K871288 DERINGER-NEY INC. GDC 1830 CASTING ALLOY 04/15/1987
K920922 DERINGER-NEY INC. GDC 3367 05/05/1992
K925273 DERINGER-NEY INC. GDC 3445 12/21/1992
K801277 DERINGER-NEY INC. GDC 934 07/21/1980
K850102 DERINGER-NEY INC. GDC-1433 A CASTING ALLOY 02/08/1985
K850103 DERINGER-NEY INC. GDC-1489 A CASTING ALLOY 02/08/1985
K850101 DERINGER-NEY INC. GDC-1629 A CASTING ALLOY 02/08/1985
K920887 DERINGER-NEY INC. GDC-3338, DENTAL SOLDER ALLOY 03/19/1992
K790641 DERINGER-NEY INC. GDC-685 05/01/1979
K792274 DERINGER-NEY INC. TEMPO 11/30/1979
K980661 EUROPEAN DENTAL IMPORTS, INC. CERA E DENTAL ALLOY 05/01/1998
K981001 EUROPEAN DENTAL IMPORTS, INC. ORION VESTA DENTAL ALLOY 05/18/1998
K981002 EUROPEAN DENTAL IMPORTS, INC. ORION WX DENTAL ALLOY 05/18/1998
K964707 GATEWAY ALLOYS, INC. SOLDER 585 12/16/1996
K964706 GATEWAY ALLOYS, INC. SOLDER 650 12/16/1996
K964713 GATEWAY ALLOYS, INC. SOLDER GPW 12/16/1996
K964705 GATEWAY ALLOYS, INC. SOLDER GPY 12/16/1996
K832425 GREAT LAKES ORTHODONTICS, LTD. GREAT LAKES PASTE SOLDER 10/04/1983
K851648 HERAEUS DENTAL GOLD CORP. HERACOR SYSTEM HERACOR PLATINUM FOIL, BLENDGOLD NE 06/04/1985
K800994 HOWMEDICA CORP. AUSTRY ALLOY(DENTAL BAKE-ON ALLOY) 05/02/1980
K820432 HOWMEDICA CORP. CLASS OF CASTING ALLOYS TYPE I OR ALTER 03/11/1982
K820433 HOWMEDICA CORP. CLASS OF CASTING ALLOYS TYPE II OR ALTER 03/11/1982
K820434 HOWMEDICA CORP. CLASS OF CASTING ALLOYS TYPE III OR ALT 03/11/1982
K820408 HOWMEDICA CORP. CLASS OF CASTING ALLOYS TYPE IV OR ALT 03/02/1982
K820407 HOWMEDICA CORP. CLASS OF PRECIOUS METAL CASTING ALLOYS 03/02/1982
K791973 HOWMEDICA CORP. HOWMEDICA A-35 DENTAL ALLOY 11/20/1979
K792008 HOWMEDICA CORP. HOWMEDICA AG-PD CROWN AND BRIDGE ALLOY 11/20/1979
K810380 HOWMEDICA CORP. HOWMEDICA T-III "G" ALLOY 03/17/1981
K820530 HOWMEDICA CORP. T-IV ELITE ALLOY 03/19/1982
K920560 INVOCLAR NORTH AMERICA, INC. DW236-34 ALLOY FOR PORCELAIN FUSED TO METAL 03/02/1992
K984451 IVOCLAR NORTH AMERICA, INC. D-SIGN I (R&D PROJECT DW263 #24) 01/19/1999
K990077 IVOCLAR NORTH AMERICA, INC. D-SIGN III (R&D PROJECT DW264#7) 02/12/1999
K990078 IVOCLAR NORTH AMERICA, INC. D-SIGN IV (R&D PROJECT DW265#37) 02/12/1999
K920613 IVOCLAR NORTH AMERICA, INC. DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL 04/21/1992
K003632 IVOCLAR NORTH AMERICA, INC. DW 273 #1 12/20/2000
K902376 IVOCLAR NORTH AMERICA, INC. DW231 DENTAL ALLOY 06/28/1990
K904876 IVOCLAR NORTH AMERICA, INC. DW237 04/17/1991
K913069 IVOCLAR NORTH AMERICA, INC. DW238 #228-04B 10/02/1991
K913068 IVOCLAR NORTH AMERICA, INC. DW238 #228-34A 10/02/1991
K901099 IVOCLAR NORTH AMERICA, INC. PROTOCOL (ALLOY) 04/25/1990
K001469 IVOCLAR NORTH AMERICA, INC. R&D PROJECT DW269#25 07/05/2000
K913070 IVOCLAR NORTH AMERICA, INC. X-L (DW228-14A) AND X-LX (DW228-24A) 09/13/1991
K923644 IVOCLAR USA, INC. DW243-64 11/04/1992
K041433 IVOCLAR VIVADENT, INC. BRIGHT GOLD XH 08/19/2004
K014082 IVOCLAR VIVADENT, INC. D.SIGN 53, MODEL NA1012204 01/30/2002
K013809 IVOCLAR VIVADENT, INC. D.SIGN 59 02/07/2002
K014042 IVOCLAR VIVADENT, INC. D.SIGN 84 02/22/2002
K821590 J. ADERER, INC. "PORS-ON" 06/14/1982
K821798 J. ADERER, INC. 82 ALLOY 07/13/1982
K820955 J. ADERER, INC. BOND-ON 05/05/1982
K821299 J. ADERER, INC. CER-MATE 05/28/1982
K821832 J. ADERER, INC. DEGUCAST "U" 07/06/1982
K821407 J. ADERER, INC. DEVA M 06/09/1982
K821572 J. ADERER, INC. DUALLOR 'R' 06/14/1982
K813418 J. ADERER, INC. INZOMA NP 01/07/1982
K821022 J. ADERER, INC. PRECIOUS METAL ALLOYS 05/10/1982
K922446 J.F. JELENKO & CO., INC. ACCU-STAR 08/05/1992
K984587 J.F. JELENKO & CO., INC. ALLROUND-E (CODE NAME RD 1710) 03/17/1999
K922450 J.F. JELENKO & CO., INC. BENCHMARK C 08/05/1992
K922448 J.F. JELENKO & CO., INC. BENCHMARK I 08/05/1992
K922447 J.F. JELENKO & CO., INC. BENCHMARK III 08/05/1992
K000532 J.F. JELENKO & CO., INC. JEL 15 04/06/2000
K012303 J.F. JELENKO & CO., INC. JEL-20 08/22/2001
K981257 J.F. JELENKO & CO., INC. JELFINE-52 (CODE NAME RD-0901) 08/13/1998
K922451 J.F. JELENKO & CO., INC. LEGACY-XT 08/05/1992
K922449 J.F. JELENKO & CO., INC. PA-400 08/05/1992
K981247 J.F. JELENKO & CO., INC. SILCAST (CODE NAME RD-0118) 07/01/1998
K912194 JELENKO CO. PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE 07/30/1991
K912195 JELENKO CO. PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE 07/30/1991
K833774 JENERIC IND. NATURELLE II & LITE II-N72-N74-L 01/24/1984
K833049 JENERIC IND. PALLADENT 10/28/1983
K833050 JENERIC IND. RX 90 10/28/1983
K840563 JENERIC IND. RX C & B 20 05/01/1984
K840561 JENERIC IND. RX ELAN 05/01/1984
K822950 JENERIC IND. RX UNIVERSAL 10/22/1982
K926146 JENERIC/PENTRON, INC. BIO C & B 05/27/1993
K925331 JENERIC/PENTRON, INC. CORRECT AND CORRECT FIT II 05/27/1993
K934757 JENERIC/PENTRON, INC. CU-FREE & LTA 02/04/1994
K926147 JENERIC/PENTRON, INC. GOLD-PLATINUM BASED CASTING ALLOY 05/27/1993
K922956 JENERIC/PENTRON, INC. KB40-KF 09/14/1992
K922958 JENERIC/PENTRON, INC. KB58-KF 02/26/1993
K926145 JENERIC/PENTRON, INC. NUGOLD 2% 05/05/1993
K922957 JENERIC/PENTRON, INC. PARAGON 09/14/1992
K890811 JENERIC/PENTRON, INC. RX APF (CASTING ALLOY) 03/17/1989
K922955 JENERIC/PENTRON, INC. ZENON PLUS 12/23/1992
K812101 JOHNSON & JOHNSON PROFESSIONALS, INC. BAK-ON SP PORCELAIN ALLOY 08/18/1981
K833434 JOHNSON & JOHNSON PROFESSIONALS, INC. CERAMCO * HIGH FUSING FOIL SOLDER 12/29/1983
K760379 L.D. CAULK CO. DENTAL AMALGAM ALLOY (SPHERICAL II) 08/23/1976
K935388 METALOR CERAPALL 4CF 01/06/1994
K912314 METALOR DENTAL USA CORP. 800 SOLDER 07/02/1991
K970044 METALOR DENTAL USA CORP. AUROFLUID 22 03/05/1997
K993475 METALOR DENTAL USA CORP. AUROFLUID M, ALLOY NO. 5315 12/09/1999
K911671 METALOR DENTAL USA CORP. CERADELTA 07/10/1991
K911670 METALOR DENTAL USA CORP. CERAPALL 06/18/1991
K911668 METALOR DENTAL USA CORP. CERAPALL 2 06/27/1991
K911669 METALOR DENTAL USA CORP. CERAPALL 6 08/16/1991
K924292 METALOR DENTAL USA CORP. CERAPALL 6 -- MODIFIED 03/01/1993
K911674 METALOR DENTAL USA CORP. CERAPLUS 08/16/1991
K993474 METALOR DENTAL USA CORP. DELTAPAL, ALLOY NO. 5161 12/02/1999
K911675 METALOR DENTAL USA CORP. PAGALIN 2 06/27/1991
K993506 METALOR DENTAL USA CORP. PAGALINOR 4 , ALLOY NO. 5440 12/08/1999
K914627 METALOR DENTAL USA CORP. PLATINUM FOIL PLATINUM MILING WAFER 11/13/1991
K911677 METALOR DENTAL USA CORP. SELECTOR 3 06/27/1991
K970045 METALOR DENTAL USA CORP. SOLARO 33 03/05/1997
K912303 METALOR DENTAL USA CORP. STANDARD S1 06/26/1991
K912304 METALOR DENTAL USA CORP. STANDARD S2 06/26/1991
K912305 METALOR DENTAL USA CORP. STANDARD S3 08/09/1991
K912307 METALOR DENTAL USA CORP. STANDARD S31 08/09/1991
K912308 METALOR DENTAL USA CORP. STANDARD S32 08/09/1991
K912309 METALOR DENTAL USA CORP. STANDARD S33 06/26/1991
K912306 METALOR DENTAL USA CORP. STANDARD S4 06/26/1991
K911545 METALOR DENTAL USA CORP. V-DELTA 07/02/1991
K972683 METALOR DENTAL USA CORP. V-DELTA 450 08/18/1997
K912315 METALOR DENTAL USA CORP. V-DELTA S1 07/02/1991
K993505 METALOR DENTAL USA CORP. V-DELTA SPECIAL, ALLOY NO. 5154 12/08/1999
K912302 METALOR DENTAL USA CORP. VACU 2 08/09/1991
K933563 METALOR DENTAL USA CORP. VS 1A 10/20/1993
K912298 METALOR DENTAL USA CORP. VS1 06/26/1991
K912300 METALOR DENTAL USA CORP. VS11 06/26/1991
K912299 METALOR DENTAL USA CORP. VS1B 06/26/1991
K813200 NEY GDC-1136 CASTING ALLOY FOR PORCELAIN-FU 12/31/1981
K941625 RMS DIV. DW234 #29 06/22/1994
K022252 STERNGOLD STERNGOLD 1, MODEL 1127781 09/19/2002
K021367 STERNGOLD STERNGOLD 66, MODEL #1180230 05/16/2002
K962304 STERNGOLD/IMPLAMED STERNGOLD BIO-4 07/23/1996
K962324 STERNGOLD/IMPLAMED STERNGOLD U-CPF METAL ALLOY (1067800) 07/24/1996
K962301 THE STERN METALS CO., INC. STERNGOLD G-HARD METAL ALLOY 07/18/1996
K800951 U.S. SHIZAI CORP. CASTA-LLOY 05/08/1980
K831097 UNITEK CORP. CONCERTO 06/15/1983
K831096 UNITEK CORP. STROMA II 06/15/1983
K832253 UNITEK CORP. X-704 08/31/1983
K022469 WIELAND DENTAL + TECHNIK GMBH & CO. KG ECO E4 09/18/2002
K020194 WIELAND DENTAL + TECHNIK GMBH & CO. KG SIMIDUR KF PLUS 03/15/2002
K020195 WIELAND DENTAL + TECHNIK GMBH & CO. KG SIMIDUR S1S 03/15/2002
K020192 WIELAND DENTAL + TECHNIK GMBH & CO. KG SIMIDUR S2 03/15/2002
K040436 WIELAND DENTAL + TECHNIK GMBH & CO. KG SIMIDUR SUPERIOR 03/05/2004
K012841 WIELAND EDELMETALLE GMBH & CO. DUO PAL 6, ORDER-NO.: 2154 11/20/2001
K012840 WIELAND EDELMETALLE GMBH & CO. EURO 45, ORDER-NO.: 2064 10/23/2001
K012828 WIELAND EDELMETALLE GMBH & CO. PORTA SMK 82, MODEL 2032 11/01/2001
K821510 WILLIAMS GOLD REFINING CO., INC. A THENIUM 06/09/1982
K852093 WILLIAMS GOLD REFINING CO., INC. ALLOY 7 08/23/1985
K855182 WILLIAMS GOLD REFINING CO., INC. ALLOY FOR METAL CROWN & BRIDGE YELLOW PD #46 & #65 03/25/1986
K860439 WILLIAMS GOLD REFINING CO., INC. DW217 #18 CROWN/BRIDGE & DW218 #24 CERAMIC ALLOYS 03/20/1986
K822419 WILLIAMS GOLD REFINING CO., INC. NEW CROWN AND BRIDGE ALLOY NO. DW196 08/30/1982
K811563 WILLIAMS GOLD REFINING CO., INC. PRESOLDER FOR NON-PRECIOUS DENTAL ALLOYS 07/28/1981
K850699 WILLIAMS GOLD REFINING CO., INC. SPARTAN -ALLOY FOR PORCELAIN FUSED TO METAL 03/18/1985
K771145 WILLIAMS GOLD REFINING CO., INC. WILL-CERAM W-2 07/15/1977
K771596 WILLIAMS GOLD REFINING CO., INC. WILL-CERAM W-3 08/26/1977


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