Alloy, Gold-Based Noble Metal

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

627510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K052463Prometal HN86EJT · Traditional Prometal Technologies10/14/2005SE
K041378Bio 60EJT · Traditional Kodent, Inc.08/02/2004SE
K040672Porta ReflexEJT · Traditional Wieland Dental + Technik GmbH & Co. KG05/27/2004SE
K040524Porta Solder 1090 WEJT · Traditional Wieland Dental + Technik GmbH & Co. KG05/20/2004SE
K040043NDX-40 AlloyEJT · Traditional Heraeus Kulzer, Inc.03/03/2004SE
K034049Herador Ec, PF, C, H, NH, G, GG and MP; Heraloy U and G; Herabond N; Albabond C, B and…EJT · Traditional Heraeus Kulzer,GmbH03/01/2004SE
K033279Gold Dental Casting AlloysEJT · Traditional Bego U.S.A.01/15/2004SE
K033446APEX93, APEX87, APEX84, APEX85, APEX77, E-Sarang 88 and E-Sarang 82EJT · Traditional We Dong Myung Dental Industrial Co., Ltd.11/13/2003SE
K033435E-Sarang 86, DM78, DM55EJT · Traditional We Dong Myung Dental Industrial Co., Ltd.11/12/2003SE
K032320Appollo 3 AlloyEJT · Traditional Dentsply International10/01/2003SE
K032321Cera F AlloyEJT · Traditional Dentsply International09/30/2003SE
K032319Cera R Plus AlloyEJT · Traditional Dentsply International09/30/2003SE
K032318Minerva 58 AlloyEJT · Traditional Dentsply International09/30/2003SE
K032317Orion GX AlloyEJT · Traditional Dentsply Intl.09/30/2003SE
K032316Orion E AlloyEJT · Traditional Dentsply Intl.09/30/2003SE
K032851Ultracrown 75 AlloyEJT · Special Dentsply International09/26/2003SE
K032715DW 296 #15 SolderEJT · Traditional Ivoclar Vivadent, Inc.09/26/2003SE
K032267R&D Designation AP-052-5EJT · Traditional Jensen Industries, Inc.09/17/2003SE
K032493AlexanderEJT · Traditional Ivoclar Vivadent, Inc.09/04/2003SE
K032106Starbond Dental Bonding AlloysEJT · Traditional Star Refining Precious Metals South Africa08/25/2003SE
K031010Miracle 98EJT · Traditional Sb Lucius, Inc.06/25/2003SE
K031264Porta PressoverEJT · Traditional Wieland Dental + Technik GmbH & Co. KG06/12/2003SE
K031543Starcast Dental AlloysEJT · Traditional Star Refining Precious Metals South Africa05/30/2003SE
K030436Bio UniversalEJT · Traditional Ivoclar Vivadent, Inc.04/15/2003SE
K030435Biouniversal PKFEJT · Traditional Ivoclar Vivadent, Inc.04/15/2003SE
K030312Porta ImplantEJT · Traditional Wieland Dental + Technik GmbH & Co. KG03/26/2003SE
K024143Aigis-FineEJT · Traditional Sb Lucius, Inc.03/10/2003SE
K024142Aigis-SuperEJT · Traditional Sb Lucius, Inc.03/10/2003SE
K024136Aigis-SoftEJT · Traditional Sb Lucius, Inc.03/10/2003SE
K024135Aigis-PlusEJT · Traditional Sb Lucius, Inc.03/10/2003SE
K024145Aigis-XoEJT · Traditional Sb Lucius, Inc.03/07/2003SE
K024144Aigis-PtEJT · Traditional Sb Lucius, Inc.03/07/2003SE
K024139Aigis-InlayEJT · Traditional Sb Lucius, Inc.03/07/2003SE
K024141Neo 76EJT · Traditional Sb Lucius, Inc.03/06/2003SE
K024140Aigis-AEJT · Traditional Sb Lucius, Inc.03/06/2003SE
K030206Apex 90EJT · Traditional We Dong Myung Dental Industrial Co., Ltd.01/29/2003SE
K023831Ucp Dental MaterialEJT · Traditional Precious Chemicals U.S.A., Inc.01/24/2003SE
K023790Ucc Dental MaterialEJT · Traditional Precious Chemicals U.S.A., Inc.01/21/2003SE
K023501Gold Core 35EJT · Traditional Pentron Laboratory Technologies12/18/2002SE
K023395Portadur P2EJT · Traditional Wieland Dental + Technik GmbH & Co. KG12/11/2002SE
K023391Bioporta GEJT · Traditional Wieland Dental + Technik GmbH & Co. KG12/10/2002SE
K023392Agc Special AlloyEJT · Traditional Wieland Dental + Technik GmbH & Co. KG12/06/2002SE
K023389Porta Geo TiEJT · Traditional Wieland Dental + Technik GmbH & Co. KG12/06/2002SE
K023197Ceranum 82EJT · Traditional Sb Lucius, Inc.11/05/2002SE
K023200Ceranum 76EJT · Traditional Sb Lucius, Inc.11/04/2002SE
K023199Ceranum 50EJT · Traditional Sb Lucius, Inc.11/04/2002SE
K023198Ceranum 90EJT · Traditional Sb Lucius, Inc.11/01/2002SE
K023196Lucius 76EJT · Traditional Sb Lucius, Inc.11/01/2002SE
K022663KeradecEJT · Traditional Wieland Dental + Technik GmbH & Co. KG10/31/2002SE
K022969Universal Ceramic SolderEJT · Traditional Ivoclar Vivadent, Inc.10/18/2002SE
K022811W-5EJT · Traditional Ivoclar Vivadent, Inc.10/09/2002SE
K022470Porta Solder 1080 WEJT · Traditional Wieland Dental + Technik GmbH & Co. KG09/18/2002SE
K022462Bioporta Solder 1020EJT · Traditional Wieland Dental + Technik GmbH & Co. KG09/18/2002SE
K022468Porta Optimum Solder 900EJT · Traditional Wieland Dental + Technik GmbH & Co. KG09/17/2002SE
K022467Porta Ip Solder V-2EJT · Traditional Wieland Dental + Technik GmbH & Co. KG09/17/2002SE
K022457Porta Optimum Solder 710EJT · Traditional Wieland Dental + Technik GmbH & Co. KG09/17/2002SE
K022456Porta Ip Solder V-1EJT · Traditional Wieland Dental + Technik GmbH & Co. KG09/17/2002SE
K022459Auropal Solder M-1EJT · Traditional Wieland Dental + Technik GmbH & Co. KG09/12/2002SE
K022454Porta Op Solder W-2EJT · Traditional Wieland Dental + Technik GmbH & Co. KG09/12/2002SE
K022452Porta Op Solder M-1EJT · Traditional Wieland Dental + Technik GmbH & Co. KG09/11/2002SE
K022451Auropal Solder W-2EJT · Traditional Wieland Dental + Technik GmbH & Co. KG09/11/2002SE
K021948Lucius 62EJT · Traditional Lucius Metals Com.09/03/2002SE
K022206Jensen Gold FoilEJT · Traditional Jensen Industries, Inc.08/29/2002SE
K021947Ceranum 87EJT · Traditional Lucius Metals Com.08/26/2002SE
K021926Auropal 60EJT · Traditional Wieland Dental + Technik GmbH & Co. KG07/25/2002SE
K021892Bright GoldEJT · Traditional Ivoclar Vivadent, Inc.07/25/2002SE
K021741Critertion, Model #1067511EJT · Abbreviated Sterngold06/26/2002SE
K021733Autopal 50EJT · Traditional Wieland Dental + Technik GmbH & Co. KG06/26/2002SE
K021242Portalloy 54EJT · Traditional Wieland Dental + Technik GmbH & Co. KG05/16/2002SE
K020347Agc SpeziallegierungEJT · Traditional Wieland Edelmetalle GmbH & Co.04/24/2002SE
K020949Apollo, Model 1124525EJT · Abbreviated Sterngold04/04/2002SE
K020190Portadur P 4EJT · Traditional Wieland Dental + Technik GmbH & Co. KG03/13/2002SE
K013769V-Gnathos SupraEJT · Traditional Metalor Technologies USA01/22/2002SE
K013506Yellow SpecialEJT · Traditional Metalor Technologies USA01/03/2002SE
K012839Auropal, Order-No.: 2101EJT · Traditional Wieland Edelmetalle GmbH & Co.12/31/2001SE
K013505Aurofluid PlusEJT · Traditional Metalor Technologies USA12/19/2001SE
K012877High Gold Palladium Free Ceramic SolderEJT · Traditional Ivoclar USA, Inc.11/21/2001SE
K012843Portadur P 2, Model #2031EJT · Traditional Wieland Edelmetalle GmbH & Co.11/02/2001SE
K012835Porta Maximum, Model# 2066EJT · Traditional Wieland Edelmetalle GmbH & Co.11/01/2001SE
K012834Porta Geo Ti Model #2004EJT · Traditional Wieland Edelmetalle GmbH & Co.11/01/2001SE
K012831Bio Portadur, ORDER-NO.:2017EJT · Traditional Wieland Edelmetalle GmbH & Co.11/01/2001SE
K012827Porta Aurium, Model 2067EJT · Traditional Wieland Edelmetalle GmbH & Co.11/01/2001SE
K012826Bioporta G, Model 2052EJT · Traditional Wieland Edelmetalle GmbH & Co.11/01/2001SE
K012838ERO50, Order-No.: 2070EJT · Traditional Wieland Edelmetalle GmbH & Co.10/23/2001SE
K011661Concord 88EJT · Abbreviated Gateway Alloys, Inc.08/27/2001SE
K011659Gpw-SfEJT · Traditional Gateway Alloys, Inc.08/27/2001SE
K011628Concord 82EJT · Abbreviated Gateway Alloys, Inc.07/16/2001SE
K011626Concord 72EJT · Abbreviated Gateway Alloys, Inc.07/16/2001SE
K011331JP Cast 40EJT · Traditional Jeneric/Pentron, Inc.06/22/2001SE
K011330JP Cast 50EJT · Traditional Jeneric/Pentron, Inc.06/22/2001SE
K011362Gold Core 73 LSEJT · Traditional Jeneric/Pentron, Inc.05/29/2001SE
K011036RD-3008EJT · Traditional Heraeus Kulzer, Inc.05/10/2001SE
K011023D.Sign 96EJT · Traditional Ivoclar North America, Inc.05/02/2001SE
K011022Biouniversal PDFEJT · Traditional Ivoclar North America, Inc.05/02/2001SE
K010611R & D Designation AP-047EJT · Abbreviated Jensen Industries, Inc.03/27/2001SE
K010414R & D Designation AP-035EJT · Abbreviated Jensen Industries, Inc.03/27/2001SE
K010416Heraceram 75EJT · Traditional Jelenko Co.03/08/2001SE
K010044CosmicEJT · Traditional Jeneric/Pentron, Inc.02/09/2001SE
K003603Bio Herador SG, Bio Header GG, Herador S, Bio Herador N, Herabond, Heraloy G, Albabond…EJT · Traditional Jelenko Co.01/10/2001SE
K003635DW 276 #3EJT · Traditional Ivoclar North America, Inc.12/22/2000SE
K003634DW 272 #1EJT · Traditional Ivoclar North America, Inc.12/21/2000SE
K003633DW 277 #4EJT · Traditional Ivoclar North America, Inc.12/20/2000SE
K002854Gold Core Post SolderEJT · Traditional Jeneric/Pentron, Inc.12/20/2000SE
K002815Gold Core HF Pre SolderEJT · Traditional Jeneric/Pentron, Inc.12/19/2000SE
K003007GalaxyEJT · Abbreviated Sterngold11/17/2000SE
K002872R&D Project DW271#11AEJT · Traditional Ivoclar North America, Inc.11/02/2000SE
K002675Millennium Edition 2000 Accelerated Electroforming SystemEJT · Traditional Product Development Industries, Inc.10/25/2000SE
K002826EquityEJT · Abbreviated Jensen Industries, Inc.10/24/2000SE
K002645Jel Bios PureEJT · Traditional J.F. Jelenko & Co., Inc.10/19/2000SE
K002222RD-2104EJT · Traditional J.F. Jelenko & Co., Inc.08/31/2000SE
K001482Aurenorm 75 KFEJT · Traditional Aurex SA (Pty) , Ltd.06/23/2000SE
K001481Palceram 49EJT · Traditional Aurex SA (Pty) , Ltd.06/23/2000SE
K001480Aurecast 40 BEJT · Traditional Aurex SA (Pty) , Ltd.06/21/2000SE
K001479Palceram 53EJT · Traditional Aurex SA (Pty) , Ltd.06/21/2000SE
K001478Aurecast Super InlayEJT · Traditional Aurex SA (Pty) , Ltd.06/20/2000SE
K001477Aurelux Y 84 PremiumEJT · Traditional Aurex SA (Pty) , Ltd.06/20/2000SE
K001041Agc-Gold Electrolyte for Agc-Micro, Agc-Gold Electrolyte for Agc-Speed, Agc-Goldbonder…EJT · Traditional Wieland Edelmetalle GmbH & Co.05/23/2000SE
K001260Allround 55 LFEJT · Traditional J.F. Jelenko & Co., Inc.05/17/2000SE
K001196Jel Bios 90 (Code Name RD-2401)EJT · Traditional J.F. Jelenko & Co., Inc.05/11/2000SE
K001051RX EverestEJT · Traditional Jeneric/Pentron, Inc.04/28/2000SE
K000360RX G-UniversalEJT · Traditional Jeneric/Pentron, Inc.02/18/2000SE
K993508V-Supra Plus, Alloy No. 5025EJT · Traditional Metalor Dental USA Corp.12/06/1999SE
K993507V-Supragold, Alloy No. 5024EJT · Traditional Metalor Dental USA Corp.12/06/1999SE
K993175Gold Core 75EJT · Traditional Jeneric/Pentron, Inc.10/26/1999SE
K993173Gold Core 55EJT · Traditional Jeneric/Pentron, Inc.10/26/1999SE
K993152Jel Bios 18 (Code Name Rd- 1214)EJT · Traditional J.F. Jelenko & Co., Inc.10/21/1999SE
K993136Jel Bios 10 (Code Name RD-1801)EJT · Traditional J.F. Jelenko & Co., Inc.10/21/1999SE
K991901BIO-97EJT · Traditional Jeneric/Pentron, Inc.09/07/1999SE
K990670Helioform Gold-Based AlloyEJT · Traditional C. Hafner GmbH & Co.04/02/1999SE
K984140Mainbond aEJT · Traditional J.F. Jelenko & Co., Inc.01/13/1999SE
K983082Begocer GEJT · Traditional Bego U.S.A.10/28/1998SE
K983080Aurolloyd KFEJT · Traditional Bego U.S.A.10/28/1998SE
K983079Platinlloyd 100EJT · Traditional Bego U.S.A.10/23/1998SE
K983077Bio PontostarEJT · Traditional Bego U.S.A.10/23/1998SE
K982606Aurofluid CPFEJT · Traditional Metalor Dental USA Corp.10/15/1998SE
K981244BW-1 (Code Name RD-0807)EJT · Traditional J.F. Jelenko & Co., Inc.08/13/1998SE
K980660Biogold Plus Dental AlloyEJT · Traditional European Dental Imports, Inc.04/27/1998SE
K980613Progold Electrocoping SystemEJT · Traditional Micro Dental Laboratories03/09/1998SE
K980597Carrara PDF, Carrara H, Carrara REJT · Traditional European Dental Imports, Inc.03/09/1998SE
K972946Aurelux 77EJT · Traditional Aurex Precious Metal Industries (Pty)Ltd12/19/1997SE
K973372Aurofilm 2000EJT · Traditional Metalor Dental USA Corp.11/26/1997SE
K973881Prospector Plus (Code Name : RD-0508)EJT · Traditional J.F. Jelenko & Co., Inc.11/24/1997SE
K972910Pors on LiteEJT · Traditional Degussa Corp.10/14/1997SE
K972949Aurelux Bio Y85PFEJT · Traditional Aurex Precious Metal Industries (Pty)Ltd09/18/1997SE
K972943Aurecast 92EJT · Traditional Aurex Precious Metal Industries (Pty)Ltd09/16/1997SE
K972956Palceram 82SFEJT · Traditional Aurex Precious Metal Industries (Pty)Ltd09/05/1997SE
K972955Palceram 56EJT · Traditional Aurex Precious Metal Industries (Pty)Ltd09/05/1997SE
K972954Palaurex 78EJT · Traditional Aurex Precious Metal Industries (Pty)Ltd09/05/1997SE
K972953Palaurex 76KFEJT · Traditional Aurex Precious Metal Industries (Pty)Ltd09/05/1997SE
K972952Aurebond 51EJT · Traditional Aurex Precious Metal Industries (Pty)Ltd09/05/1997SE
K972951Hipallaur 51EJT · Traditional Aurex Precious Metal Industries (Pty)Ltd09/05/1997SE
K972950Hipallaur 19EJT · Traditional Aurex Precious Metal Industries (Pty)Ltd09/05/1997SE
K972942Aurecast 83EJT · Traditional Aurex Precious Metal Industries (Pty)Ltd08/28/1997SE
K972941Aurecast 74EJT · Traditional Aurex Precious Metal Industries (Pty)Ltd08/28/1997SE
K972940Aurecast Bio 69PFEJT · Traditional Aurex Precious Metal Industries (Pty)Ltd08/26/1997SE
K972939Aurecast Bio 59PFEJT · Traditional Aurex Precious Metal Industries (Pty)Ltd08/26/1997SE
K972319Aurecast GFEJT · Traditional Aurex Precious Metal Industries (Pty)Ltd08/26/1997SE
K972938Aurecast 10EJT · Traditional Aurex Precious Metal Industries (Pty)Ltd08/25/1997SE
K972937Aurecast 4EJT · Traditional Aurex Precious Metal Industries (Pty)Ltd08/25/1997SE
K972936Aurecast 2EJT · Traditional Aurex Precious Metal Industries (Pty)Ltd08/25/1997SE
K972632Vera PD SolderEJT · Traditional Aalba Dent, Inc.08/15/1997SE
K972532Aalba Gold SolderEJT · Traditional Aalba Dent, Inc.08/15/1997SE
K971575Benchmark-IvEJT · Traditional J.F. Jelenko & Co., Inc.06/04/1997SE
K971574Jelbond-PdfEJT · Traditional J.F. Jelenko & Co., Inc.05/20/1997SE
K971292JEL-71 PDFEJT · Traditional J.F. Jelenko & Co., Inc.05/20/1997SE
K970963Targis Alloy #7EJT · Traditional Ivoclar North America, Inc.04/30/1997SE
K970068Jelenko NO.1 (Code Name RD-0601)EJT · Traditional J.F. Jelenko & Co., Inc.03/24/1997SE
K964772Aquarius HPF (Will Be Sold AS Williams Classic Visions)EJT · Traditional Ivoclar North America, Inc.01/17/1997SE
K964950La Plata 28 (PM-28)EJT · Traditional Gateway Alloys, Inc.01/13/1997SE
K964949Aurora 53EJT · Traditional Gateway Alloys, Inc.01/13/1997SE
K964948Aurora 52 (PM-01)EJT · Traditional Gateway Alloys, Inc.01/13/1997SE
K964941El Dorado 40EJT · Traditional Gateway Alloys, Inc.01/13/1997SE
K964940Taos 28EJT · Traditional Gateway Alloys, Inc.01/13/1997SE
K964838Palladia 85 (PM-13)EJT · Traditional Gateway Alloys, Inc.12/20/1996SE
K964837Pacific 56 (CB-40)EJT · Traditional Gateway Alloys, Inc.12/20/1996SE
K964792La Plata 40EJT · Traditional Gateway Alloys, Inc.12/20/1996SE
K964789La Plata 39EJT · Traditional Gateway Alloys, Inc.12/20/1996SE
K964788El Dorado 55EJT · Traditional Gateway Alloys, Inc.12/20/1996SE
K964708Solder 615EJT · Traditional Gateway Alloys, Inc.12/16/1996SE
K964158JEL-40 (Code Name RD-0430)EJT · Traditional Jelenko Co.12/13/1996SE
K964573Piedmont 70 (CH-35)EJT · Traditional Gateway Alloys, Inc.12/06/1996SE
K964572Palladia 76EJT · Traditional Gateway Alloys, Inc.12/06/1996SE
K964569El Dorado 58EJT · Traditional Gateway Alloys, Inc.12/06/1996SE
K964568Ozark 46EJT · Traditional Gateway Alloys, Inc.12/06/1996SE
K964567El Dorado 75EJT · Traditional Gateway Alloys, Inc.12/06/1996SE
K964566Ozark 20EJT · Traditional Gateway Alloys, Inc.12/06/1996SE
K964476De Oro 77EJT · Traditional Gateway Alloys, Inc.12/04/1996SE
K964477Ozark 40EJT · Traditional Gateway Alloys, Inc.12/02/1996SE
K964478Osage 76EJT · Traditional Gateway Alloys, Inc.11/26/1996SE
K964465La Plata 34 (PM-25)EJT · Traditional Gateway Alloys, Inc.11/26/1996SE
K964464Pacific 52 (CB-39)EJT · Traditional Gateway Alloys, Inc.11/26/1996SE
K964466Palladia 75 (PM-11)EJT · Traditional Gateway Alloys, Inc.11/20/1996SE
K962326Sterngold BIO-5 (1127210)EJT · Traditional Sterngold/Implamed07/24/1996SE
K962325Quasar Yellow Crown and Bridge Alloy (1122015)EJT · Traditional Sterngold/Implamed07/24/1996SE
K962303Sterngold CFEJT · Traditional Sterngold/Implamed07/18/1996SE
K962302Pegasus Dental AlloyEJT · Traditional Sterngold/Implamed07/18/1996SE
K960956Sterngold M-Pf Yellow Crown & Bridge Alloy Model 1127200EJT · Traditional Sterngold/Implamed05/29/1996SE
K961352285 SLEJT · Traditional Argen Precious Metals, Inc.05/20/1996SE
K961211Argelite 52+EJT · Traditional Argen Precious Metals, Inc.04/25/1996SE
K961285Argedent 40(GOLD-PALLADIUM-SILVER Alloy for Porcelain Application)EJT · Traditional Argen Precious Metals, Inc.04/18/1996SE