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 |
| K972945 | AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD | AURENORM 68 | 11/26/1997 |
| K983081 | BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO | BEGOPAL 300 | 10/28/1998 |
| K983078 | BEGO U.S.A. | BEGOPAL | 10/23/1998 |
| K973288 | DEGUSSA CORP. | STABILOR HN | 11/19/1997 |
| 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 |
| 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 |
| K003632 | IVOCLAR NORTH AMERICA, INC. | DW 273 #1 | 12/20/2000 |
| K001469 | IVOCLAR NORTH AMERICA, INC. | R&D PROJECT DW269#25 | 07/05/2000 |
| 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 |
| K984587 | J.F. JELENKO & CO., INC. | ALLROUND-E (CODE NAME RD 1710) | 03/17/1999 |
| 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 |
| K981247 | J.F. JELENKO & CO., INC. | SILCAST (CODE NAME RD-0118) | 07/01/1998 |
| K970044 | METALOR DENTAL USA CORP. | AUROFLUID 22 | 03/05/1997 |
| K993475 | METALOR DENTAL USA CORP. | AUROFLUID M, ALLOY NO. 5315 | 12/09/1999 |
| K993474 | METALOR DENTAL USA CORP. | DELTAPAL, ALLOY NO. 5161 | 12/02/1999 |
| K993506 | METALOR DENTAL USA CORP. | PAGALINOR 4 , ALLOY NO. 5440 | 12/08/1999 |
| K970045 | METALOR DENTAL USA CORP. | SOLARO 33 | 03/05/1997 |
| K972683 | METALOR DENTAL USA CORP. | V-DELTA 450 | 08/18/1997 |
| K993505 | METALOR DENTAL USA CORP. | V-DELTA SPECIAL, ALLOY NO. 5154 | 12/08/1999 |
| 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 |
| 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 |
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