Alloy, Other Noble Metal

FDA product code EJS · Class II (moderate risk) · 21 CFR 872.3060 · Dental

194510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K041433Bright Gold XHEJS · Traditional Ivoclar Vivadent, Inc.08/19/2004SE
K040436Simidur SuperiorEJS · Traditional Wieland Dental + Technik GmbH & Co. KG03/05/2004SE
K022252Sterngold 1, Model 1127781EJS · Abbreviated Sterngold09/19/2002SE
K022469Eco E4EJS · Traditional Wieland Dental + Technik GmbH & Co. KG09/18/2002SE
K021367Sterngold 66, Model #1180230EJS · Abbreviated Sterngold05/16/2002SE
K020195Simidur S1SEJS · Traditional Wieland Dental + Technik GmbH & Co. KG03/15/2002SE
K020194Simidur KF PlusEJS · Traditional Wieland Dental + Technik GmbH & Co. KG03/15/2002SE
K020192Simidur S2EJS · Traditional Wieland Dental + Technik GmbH & Co. KG03/15/2002SE
K014042D.Sign 84EJS · Traditional Ivoclar Vivadent, Inc.02/22/2002SE
K013809D.Sign 59EJS · Traditional Ivoclar Vivadent, Inc.02/07/2002SE
K014082D.Sign 53, Model NA1012204EJS · Traditional Ivoclar Vivadent, Inc.01/30/2002SE
K012841Duo Pal 6, Order-No.: 2154EJS · Traditional Wieland Edelmetalle GmbH & Co.11/20/2001SE
K012828Porta SMK 82, Model 2032EJS · Traditional Wieland Edelmetalle GmbH & Co.11/01/2001SE
K012840Euro 45, Order-No.: 2064EJS · Traditional Wieland Edelmetalle GmbH & Co.10/23/2001SE
K012303JEL-20EJS · Traditional J.F. Jelenko & Co., Inc.08/22/2001SE
K003632DW 273 #1EJS · Traditional Ivoclar North America, Inc.12/20/2000SE
K001469R&D Project DW269#25EJS · Traditional Ivoclar North America, Inc.07/05/2000SE
K000532Jel 15EJS · Traditional J.F. Jelenko & Co., Inc.04/06/2000SE
K993475Aurofluid M, Alloy No. 5315EJS · Traditional Metalor Dental USA Corp.12/09/1999SE
K993506Pagalinor 4 , Alloy No. 5440EJS · Traditional Metalor Dental USA Corp.12/08/1999SE
K993505V-Delta Special, Alloy No. 5154EJS · Traditional Metalor Dental USA Corp.12/08/1999SE
K993474Deltapal, Alloy No. 5161EJS · Traditional Metalor Dental USA Corp.12/02/1999SE
K984587Allround-E (Code Name RD 1710)EJS · Traditional J.F. Jelenko & Co., Inc.03/17/1999SE
K990078D-Sign IV (R&D Project DW265#37)EJS · Traditional Ivoclar North America, Inc.02/12/1999SE
K990077D-Sign III (R&D Project DW264#7)EJS · Traditional Ivoclar North America, Inc.02/12/1999SE
K984451D-Sign I (R&D Project DW263 #24)EJS · Traditional Ivoclar North America, Inc.01/19/1999SE
K983081Begopal 300EJS · Traditional Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO10/28/1998SE
K983078BegopalEJS · Traditional Bego U.S.A.10/23/1998SE
K981257JELFINE-52 (Code Name RD-0901)EJS · Traditional J.F. Jelenko & Co., Inc.08/13/1998SE
K981247Silcast (Code Name RD-0118)EJS · Traditional J.F. Jelenko & Co., Inc.07/01/1998SE
K981002Orion WX Dental AlloyEJS · Traditional European Dental Imports, Inc.05/18/1998SE
K981001Orion Vesta Dental AlloyEJS · Traditional European Dental Imports, Inc.05/18/1998SE
K980661Cera E Dental AlloyEJS · Traditional European Dental Imports, Inc.05/01/1998SE
K972945Aurenorm 68EJS · Traditional Aurex Precious Metal Industries (Pty)Ltd11/26/1997SE
K973288Stabilor HNEJS · Traditional Degussa Corp.11/19/1997SE
K972534AlfalloyEJS · Traditional Aalba Dent, Inc.09/05/1997SE
K972533Vera SolderEJS · Traditional Aalba Dent, Inc.09/05/1997SE
K972683V-Delta 450EJS · Traditional Metalor Dental USA Corp.08/18/1997SE
K970045Solaro 33EJS · Traditional Metalor Dental USA Corp.03/05/1997SE
K970044Aurofluid 22EJS · Traditional Metalor Dental USA Corp.03/05/1997SE
K964713Solder GPWEJS · Traditional Gateway Alloys, Inc.12/16/1996SE
K964707Solder 585EJS · Traditional Gateway Alloys, Inc.12/16/1996SE
K964706Solder 650EJS · Traditional Gateway Alloys, Inc.12/16/1996SE
K964705Solder GpyEJS · Traditional Gateway Alloys, Inc.12/16/1996SE
K962324Sterngold U-Cpf Metal Alloy (1067800)EJS · Traditional Sterngold/Implamed07/24/1996SE
K962304Sterngold BIO-4EJS · Traditional Sterngold/Implamed07/23/1996SE
K962301Sterngold G-Hard Metal AlloyEJS · Traditional The Stern Metals Co., Inc.07/18/1996SE
K941625DW234 #29EJS · Traditional Rms Div.06/22/1994SE
K934757Cu-Free & LtaEJS · Traditional Jeneric/Pentron, Inc.02/04/1994SE
K935388Cerapall 4CFEJS · Traditional Metalor01/06/1994SE
K934773Argelite aEJS · Traditional Argen Precious Metals, Inc.12/10/1993SE
K933563VS 1AEJS · Traditional Metalor Dental USA Corp.10/20/1993SE
K926147Gold-Platinum Based Casting AlloyEJS · Traditional Jeneric/Pentron, Inc.05/27/1993SE
K926146Bio C & BEJS · Traditional Jeneric/Pentron, Inc.05/27/1993SE
K925331Correct and Correct Fit IIEJS · Traditional Jeneric/Pentron, Inc.05/27/1993SE
K926145Nugold 2%EJS · Traditional Jeneric/Pentron, Inc.05/05/1993SE
K924292Cerapall 6 -- ModifiedEJS · Traditional Metalor Dental USA Corp.03/01/1993SE
K922958KB58-KFEJS · Traditional Jeneric/Pentron, Inc.02/26/1993SE
K922955Zenon PlusEJS · Traditional Jeneric/Pentron, Inc.12/23/1992SE
K925273GDC 3445EJS · Traditional Deringer-Ney, Inc.12/21/1992SE
K923644DW243-64EJS · Traditional Ivoclar USA, Inc.11/04/1992SE
K922957ParagonEJS · Traditional Jeneric/Pentron, Inc.09/14/1992SE
K922956KB40-KFEJS · Traditional Jeneric/Pentron, Inc.09/14/1992SE
K922451Legacy-XtEJS · Traditional J.F. Jelenko & Co., Inc.08/05/1992SE
K922450Benchmark CEJS · Traditional J.F. Jelenko & Co., Inc.08/05/1992SE
K922449PA-400EJS · Traditional J.F. Jelenko & Co., Inc.08/05/1992SE
K922448Benchmark IEJS · Traditional J.F. Jelenko & Co., Inc.08/05/1992SE
K922447Benchmark IIIEJS · Traditional J.F. Jelenko & Co., Inc.08/05/1992SE
K922446Accu-StarEJS · Traditional J.F. Jelenko & Co., Inc.08/05/1992SE
K921445Degubond PlusEJS · Traditional Degussa AG05/26/1992SE
K921419Deva PlusEJS · Traditional Degussa AG05/26/1992SE
K920922GDC 3367EJS · Traditional Deringer-Ney, Inc.05/05/1992SE
K920613DW 215-12A Alloy for Forcelain Fused to MetalEJS · Traditional Ivoclar North America, Inc.04/21/1992SE
K915165Argebond 77+EJS · Traditional Argen Precious Metals, Inc.04/21/1992SE
K920887GDC-3338, Dental Solder AlloyEJS · Traditional Deringer-Ney, Inc.03/19/1992SE
K920560DW236-34 Alloy for Porcelain Fused to MetalEJS · Traditional Invoclar North America, Inc.03/02/1992SE
K914627Platinum Foil Platinum Miling WaferEJS · Traditional Metalor Dental USA Corp.11/13/1991SE
K913860Ultracrown(Tm) PD Alloy Post-SolderEJS · Traditional Dentsply Intl.11/13/1991SE
K913704Argebond 80EJS · Traditional Argen Precious Metals, Inc.11/13/1991SE
K913069DW238 #228-04BEJS · Traditional Ivoclar North America, Inc.10/02/1991SE
K913068DW238 #228-34AEJS · Traditional Ivoclar North America, Inc.10/02/1991SE
K913070X-L (DW228-14A) and X-Lx (DW228-24A)EJS · Traditional Ivoclar North America, Inc.09/13/1991SE
K913232Ultracrown(Tm) PD Dental AlloyEJS · Traditional Dentsply Intl.09/06/1991SE
K912493Degubond LiteEJS · Traditional Degussa AG08/20/1991SE
K911674CeraplusEJS · Traditional Metalor Dental USA Corp.08/16/1991SE
K911669Cerapall 6EJS · Traditional Metalor Dental USA Corp.08/16/1991SE
K912308Standard S32EJS · Traditional Metalor Dental USA Corp.08/09/1991SE
K912307Standard S31EJS · Traditional Metalor Dental USA Corp.08/09/1991SE
K912305Standard S3EJS · Traditional Metalor Dental USA Corp.08/09/1991SE
K912302Vacu 2EJS · Traditional Metalor Dental USA Corp.08/09/1991SE
K912195PA-396 Gold Based/Precious Metal Alloys Clin UseEJS · Traditional Jelenko Co.07/30/1991SE
K912194PA-393 Gold Based/Precious Metal Alloys Clin UseEJS · Traditional Jelenko Co.07/30/1991SE
K911671CeradeltaEJS · Traditional Metalor Dental USA Corp.07/10/1991SE
K912315V-Delta S1EJS · Traditional Metalor Dental USA Corp.07/02/1991SE
K912314800 SolderEJS · Traditional Metalor Dental USA Corp.07/02/1991SE
K911545V-DeltaEJS · Traditional Metalor Dental USA Corp.07/02/1991SE
K911677Selector 3EJS · Traditional Metalor Dental USA Corp.06/27/1991SE
K911675Pagalin 2EJS · Traditional Metalor Dental USA Corp.06/27/1991SE
K911668Cerapall 2EJS · Traditional Metalor Dental USA Corp.06/27/1991SE
K912309Standard S33EJS · Traditional Metalor Dental USA Corp.06/26/1991SE
K912306Standard S4EJS · Traditional Metalor Dental USA Corp.06/26/1991SE
K912304Standard S2EJS · Traditional Metalor Dental USA Corp.06/26/1991SE
K912303Standard S1EJS · Traditional Metalor Dental USA Corp.06/26/1991SE
K912300VS11EJS · Traditional Metalor Dental USA Corp.06/26/1991SE
K912299VS1BEJS · Traditional Metalor Dental USA Corp.06/26/1991SE
K912298VS1EJS · Traditional Metalor Dental USA Corp.06/26/1991SE
K911757MaxibondEJS · Traditional Argen Precious Metals, Inc.06/18/1991SE
K911670CerapallEJS · Traditional Metalor Dental USA Corp.06/18/1991SE
K910467ArgiplusEJS · Traditional Argen Precious Metals, Inc.04/30/1991SE
K904876DW237EJS · Traditional Ivoclar North America, Inc.04/17/1991SE
K903971Argenco 26BEJS · Traditional Argen Precious Metals, Inc.12/17/1990SE
K903060Argenco 34EJS · Traditional Argen Precious Metals, Inc.08/13/1990SE
K903009Argenco IIIEJS · Traditional Argen Precious Metals, Inc.08/13/1990SE
K902665Argenco Y (Type Iii/Iv Dental Alloy Crown/BridgeEJS · Traditional Argen Precious Metals, Inc.08/07/1990SE
K902376DW231 Dental AlloyEJS · Traditional Ivoclar North America, Inc.06/28/1990SE
K901099Protocol (Alloy)EJS · Traditional Ivoclar North America, Inc.04/25/1990SE
K890811RX Apf (Casting Alloy)EJS · Traditional Jeneric/Pentron, Inc.03/17/1989SE
K883511Albabond EEJS · Traditional Degussa Dental, Inc.10/06/1988SE
K883509Heraeus DG 63EJS · Traditional Degussa Dental, Inc.09/22/1988SE
K883510Degupal 4EJS · Traditional Degussa Dental, Inc.09/15/1988SE
K883507Heraeus C SpecialEJS · Traditional Degussa Dental, Inc.09/15/1988SE
K883512Heraeus WhiteEJS · Traditional Degussa Dental, Inc.09/06/1988SE
K874821Lunar Casting Alloy for Porcelain-Fused-To-MetalEJS · Traditional Deringer-Ney, Inc.02/08/1988SE
K873373SinterloyEJS · Traditional Denpac Corp.10/27/1987SE
K871288GDC 1830 Casting AlloyEJS · Traditional Deringer-Ney, Inc.04/15/1987SE
K864162DegupalEJS · Traditional Degussa Dental, Inc.11/03/1986SE
K862856Palladium Based Dent Alloys/Porcelain Metal RestorEJS · Traditional Austenal Dental, Inc.08/26/1986SE
K860964White Silver Solder and Yellow Silver SolderEJS · Traditional Austenal Dental, Inc.03/26/1986SE
K855182Alloy for Metal Crown & Bridge Yellow PD #46 & #65EJS · Traditional Williams Gold Refining Co., Inc.03/25/1986SE
K860439DW217 #18 Crown/Bridge & DW218 #24 Ceramic AlloysEJS · Traditional Williams Gold Refining Co., Inc.03/20/1986SE
K860299Realor AlloyEJS · Traditional Degussa Dental, Inc.03/17/1986SE
K860119GDC 1742 (a Casting Alloy for Dental Restorations)EJS · Traditional Deringer-Ney, Inc.03/17/1986SE
K852093Alloy 7EJS · Traditional Williams Gold Refining Co., Inc.08/23/1985SE
K852347Dental Casting Alloy GDC 1686EJS · Traditional Deringer-Ney, Inc.07/31/1985SE
K851648Heracor System Heracor Platinum Foil, Blendgold NeEJS · Traditional Heraeus Dental Gold Corp.06/04/1985SE
K850699Spartan -Alloy for Porcelain Fused to MetalEJS · Traditional Williams Gold Refining Co., Inc.03/18/1985SE
K850193Pors-On Hf-Solder(Porcelain Dental Alloys)EJS · Traditional Degussa Dental, Inc.02/08/1985SE
K850103GDC-1489 a Casting AlloyEJS · Traditional Deringer-Ney, Inc.02/08/1985SE
K850102GDC-1433 a Casting AlloyEJS · Traditional Deringer-Ney, Inc.02/08/1985SE
K850101GDC-1629 a Casting AlloyEJS · Traditional Deringer-Ney, Inc.02/08/1985SE
K840563RX C & B 20EJS · Traditional Jeneric Ind.05/01/1984SE
K840561RX ElanEJS · Traditional Jeneric Ind.05/01/1984SE
K840014Chemodent Ceramic MetalEJS · Traditional Chemodent Metal Co.03/30/1984SE
K833774Naturelle II & Lite II-N72-N74-LEJS · Traditional Jeneric Ind.01/24/1984SE
K833596GDC 1448 Development NameEJS · Traditional Deringer-Ney, Inc.12/29/1983SE
K833434Ceramco * High Fusing Foil SolderEJS · Traditional Johnson & Johnson Professionals, Inc.12/29/1983SE
K833445Deguplus 2EJS · Traditional Degussa Dental, Inc.12/26/1983SE
K833050RX 90EJS · Traditional Jeneric Ind.10/28/1983SE
K833049PalladentEJS · Traditional Jeneric Ind.10/28/1983SE
K832425Great Lakes Paste SolderEJS · Traditional Great Lakes Orthodontics, Ltd.10/04/1983SE
K832530Deva 4EJS · Traditional Degussa Dental, Inc.09/29/1983SE
K832253X-704EJS · Traditional Unitek Corp.08/31/1983SE
K831097ConcertoEJS · Traditional Unitek Corp.06/15/1983SE
K831096Stroma IIEJS · Traditional Unitek Corp.06/15/1983SE
K823100RX 91EJS · Traditional Bauer, Cheng & Associates, Inc.11/10/1982SE
K823097NaturelleEJS · Traditional Bauer, Cheng & Associates, Inc.11/10/1982SE
K823084ChallengerEJS · Traditional Bauer, Cheng & Associates, Inc.11/10/1982SE
K822950RX UniversalEJS · Traditional Jeneric Ind.10/22/1982SE
K822419New Crown and Bridge Alloy No. DW196EJS · Traditional Williams Gold Refining Co., Inc.08/30/1982SE
K82179882 AlloyEJS · Traditional J. Aderer, Inc.07/13/1982SE
K821832Degucast UEJS · Traditional J. Aderer, Inc.07/06/1982SE
K821590Pors-OnEJS · Traditional J. Aderer, Inc.06/14/1982SE
K821572Duallor 'R'EJS · Traditional J. Aderer, Inc.06/14/1982SE
K821510A TheniumEJS · Traditional Williams Gold Refining Co., Inc.06/09/1982SE
K821407Deva MEJS · Traditional J. Aderer, Inc.06/09/1982SE
K821299Cer-MateEJS · Traditional J. Aderer, Inc.05/28/1982SE
K821022Precious Metal AlloysEJS · Traditional J. Aderer, Inc.05/10/1982SE
K820955Bond-OnEJS · Traditional J. Aderer, Inc.05/05/1982SE
K820530T-Iv Elite AlloyEJS · Traditional Howmedica Corp.03/19/1982SE
K820434Class of Casting Alloys Type III or AltEJS · Traditional Howmedica Corp.03/11/1982SE
K820433Class of Casting Alloys Type II or AlterEJS · Traditional Howmedica Corp.03/11/1982SE
K820432Class of Casting Alloys Type I or AlterEJS · Traditional Howmedica Corp.03/11/1982SE
K820408Class of Casting Alloys Type IV or AltEJS · Traditional Howmedica Corp.03/02/1982SE
K820407Class of Precious Metal Casting AlloysEJS · Traditional Howmedica Corp.03/02/1982SE
K813418Inzoma NPEJS · Traditional J. Aderer, Inc.01/07/1982SE
K813200GDC-1136 Casting Alloy for Porcelain-FuEJS · Traditional Ney12/31/1981SE
K812101Bak-On SP Porcelain AlloyEJS · Traditional Johnson & Johnson Professionals, Inc.08/18/1981SE
K811563Presolder for Non-Precious Dental AlloysEJS · Traditional Williams Gold Refining Co., Inc.07/28/1981SE
K810380Howmedica T-Iii G AlloyEJS · Traditional Howmedica Corp.03/17/1981SE
K801277GDC 934EJS · Traditional Deringer-Ney, Inc.07/21/1980SE
K801009Howmedica White C&B AlloyEJS · Traditional Dental Laboratory Products Div.06/04/1980SE
K800951Casta-LloyEJS · Traditional U.S. Shizai Corp.05/08/1980SE
K800994Austry Alloy(Dental Bake-On Alloy)EJS · Traditional Howmedica Corp.05/02/1980SE
K792274TempoEJS · Traditional Deringer-Ney, Inc.11/30/1979SE
K792008Howmedica Ag-Pd Crown and Bridge AlloyEJS · Traditional Howmedica Corp.11/20/1979SE
K791973Howmedica A-35 Dental AlloyEJS · Traditional Howmedica Corp.11/20/1979SE
K791005Chemodent Ceramic MetalEJS · Traditional Chemodent Dental Laboratory08/10/1979SE
K790641GDC-685EJS · Traditional Deringer-Ney, Inc.05/01/1979SE
K790097Salivan & Salivan BrownEJS · Traditional Den-Mat Corp.02/26/1979SE
K790096Salivan Paraeight ToughnessEJS · Traditional Den-Mat Corp.02/26/1979SE
K771596Will-Ceram W-3EJS · Traditional Williams Gold Refining Co., Inc.08/26/1977SE
K771145Will-Ceram W-2EJS · Traditional Williams Gold Refining Co., Inc.07/15/1977SE
K760783Biobond-Crown & Bridge Ceramic BondingEJS · Traditional Dentsply Intl.10/15/1976SE
K760379Dental Amalgam Alloy (Spherical II)EJS · Traditional L.D. Caulk Co.08/23/1976SE