Dental

EJS · Alloy, Other Noble Metal

Dental · 21 CFR 872.3060 · Class 2

Overview

Product CodeEJS
Device NameAlloy, Other Noble Metal
Regulation21 CFR 872.3060
Device ClassClass 2
Review PanelDental

Identification

A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.

Classification Rationale

Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.

Special Controls

*Classification.* Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.

Cleared Devices (194)

RecordDevice NameApplicantDecision DateDecision
K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.Aug 19, 2004SESE
K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KGMar 5, 2004SESE
K022252STERNGOLD 1, MODEL 1127781SterngoldSep 19, 2002SESE
K022469ECO E4Wieland Dental + Technik GmbH & Co. KGSep 18, 2002SESE
K021367STERNGOLD 66, MODEL #1180230SterngoldMay 16, 2002SESE
K020195SIMIDUR S1SWieland Dental + Technik GmbH & Co. KGMar 15, 2002SESE
K020194SIMIDUR KF PLUSWieland Dental + Technik GmbH & Co. KGMar 15, 2002SESE
K020192SIMIDUR S2Wieland Dental + Technik GmbH & Co. KGMar 15, 2002SESE
K014042D.SIGN 84Ivoclar Vivadent, Inc.Feb 22, 2002SESE
K013809D.SIGN 59Ivoclar Vivadent, Inc.Feb 7, 2002SESE
K014082D.SIGN 53, MODEL NA1012204Ivoclar Vivadent, Inc.Jan 30, 2002SESE
K012841DUO PAL 6, ORDER-NO.: 2154Wieland Edelmetalle GmbH & Co.Nov 20, 2001SESE
K012828PORTA SMK 82, MODEL 2032Wieland Edelmetalle GmbH & Co.Nov 1, 2001SESE
K012840EURO 45, ORDER-NO.: 2064Wieland Edelmetalle GmbH & Co.Oct 23, 2001SESE
K012303JEL-20J.F. Jelenko & Co., Inc.Aug 22, 2001SESE
K003632DW 273 #1Ivoclar North America, Inc.Dec 20, 2000SESE
K001469R&D PROJECT DW269#25Ivoclar North America, Inc.Jul 5, 2000SESE
K000532JEL 15J.F. Jelenko & Co., Inc.Apr 6, 2000SESE
K993475AUROFLUID M, ALLOY NO. 5315Metalor Dental USA Corp.Dec 9, 1999SESE
K993506PAGALINOR 4 , ALLOY NO. 5440Metalor Dental USA Corp.Dec 8, 1999SESE
K993505V-DELTA SPECIAL, ALLOY NO. 5154Metalor Dental USA Corp.Dec 8, 1999SESE
K993474DELTAPAL, ALLOY NO. 5161Metalor Dental USA Corp.Dec 2, 1999SESE
K984587ALLROUND-E (CODE NAME RD 1710)J.F. Jelenko & Co., Inc.Mar 17, 1999SESE
K990078D-SIGN IV (R&D PROJECT DW265#37)Ivoclar North America, Inc.Feb 12, 1999SESE
K990077D-SIGN III (R&D PROJECT DW264#7)Ivoclar North America, Inc.Feb 12, 1999SESE
K984451D-SIGN I (R&D PROJECT DW263 #24)Ivoclar North America, Inc.Jan 19, 1999SESE
K983081BEGOPAL 300Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & COOct 28, 1998SESE
K983078BEGOPALBego U.S.A.Oct 23, 1998SESE
K981257JELFINE-52 (CODE NAME RD-0901)J.F. Jelenko & Co., Inc.Aug 13, 1998SESE
K981247SILCAST (CODE NAME RD-0118)J.F. Jelenko & Co., Inc.Jul 1, 1998SESE
K981002ORION WX DENTAL ALLOYEuropean Dental Imports, Inc.May 18, 1998SESE
K981001ORION VESTA DENTAL ALLOYEuropean Dental Imports, Inc.May 18, 1998SESE
K980661CERA E DENTAL ALLOYEuropean Dental Imports, Inc.May 1, 1998SESE
K972945AURENORM 68Aurex Precious Metal Industries (Pty)LtdNov 26, 1997SESE
K973288STABILOR HNDegussa Corp.Nov 19, 1997SESE
K972534ALFALLOYAalba Dent, Inc.Sep 5, 1997SESE
K972533VERA SOLDERAalba Dent, Inc.Sep 5, 1997SESE
K972683V-DELTA 450Metalor Dental USA Corp.Aug 18, 1997SESE
K970045SOLARO 33Metalor Dental USA Corp.Mar 5, 1997SESE
K970044AUROFLUID 22Metalor Dental USA Corp.Mar 5, 1997SESE
K964713SOLDER GPWGateway Alloys, Inc.Dec 16, 1996SESE
K964707SOLDER 585Gateway Alloys, Inc.Dec 16, 1996SESE
K964706SOLDER 650Gateway Alloys, Inc.Dec 16, 1996SESE
K964705SOLDER GPYGateway Alloys, Inc.Dec 16, 1996SESE
K962324STERNGOLD U-CPF METAL ALLOY (1067800)Sterngold/ImplamedJul 24, 1996SESE
K962304STERNGOLD BIO-4Sterngold/ImplamedJul 23, 1996SESE
K962301STERNGOLD G-HARD METAL ALLOYThe Stern Metals Co., Inc.Jul 18, 1996SESE
K941625DW234 #29Rms Div.Jun 22, 1994SESE
K934757CU-FREE & LTAJeneric/Pentron, Inc.Feb 4, 1994SESE
K935388CERAPALL 4CFMetalorJan 6, 1994SESE
K934773ARGELITE AArgen Precious Metals, Inc.Dec 10, 1993SESE
K933563VS 1AMetalor Dental USA Corp.Oct 20, 1993SESE
K926147GOLD-PLATINUM BASED CASTING ALLOYJeneric/Pentron, Inc.May 27, 1993SESE
K926146BIO C & BJeneric/Pentron, Inc.May 27, 1993SESE
K925331CORRECT AND CORRECT FIT IIJeneric/Pentron, Inc.May 27, 1993SESE
K926145NUGOLD 2%Jeneric/Pentron, Inc.May 5, 1993SESE
K924292CERAPALL 6 -- MODIFIEDMetalor Dental USA Corp.Mar 1, 1993SESE
K922958KB58-KFJeneric/Pentron, Inc.Feb 26, 1993SESE
K922955ZENON PLUSJeneric/Pentron, Inc.Dec 23, 1992SESE
K925273GDC 3445Deringer-Ney, Inc.Dec 21, 1992SESE
K923644DW243-64Ivoclar USA, Inc.Nov 4, 1992SESE
K922957PARAGONJeneric/Pentron, Inc.Sep 14, 1992SESE
K922956KB40-KFJeneric/Pentron, Inc.Sep 14, 1992SESE
K922451LEGACY-XTJ.F. Jelenko & Co., Inc.Aug 5, 1992SESE
K922450BENCHMARK CJ.F. Jelenko & Co., Inc.Aug 5, 1992SESE
K922449PA-400J.F. Jelenko & Co., Inc.Aug 5, 1992SESE
K922448BENCHMARK IJ.F. Jelenko & Co., Inc.Aug 5, 1992SESE
K922447BENCHMARK IIIJ.F. Jelenko & Co., Inc.Aug 5, 1992SESE
K922446ACCU-STARJ.F. Jelenko & Co., Inc.Aug 5, 1992SESE
K921445DEGUBOND PLUSDegussa AGMay 26, 1992SESE
K921419DEVA PLUSDegussa AGMay 26, 1992SESE
K920922GDC 3367Deringer-Ney, Inc.May 5, 1992SESE
K920613DW 215-12A ALLOY FOR FORCELAIN FUSED TO METALIvoclar North America, Inc.Apr 21, 1992SESE
K915165ARGEBOND 77+Argen Precious Metals, Inc.Apr 21, 1992SESE
K920887GDC-3338, DENTAL SOLDER ALLOYDeringer-Ney, Inc.Mar 19, 1992SESE
K920560DW236-34 ALLOY FOR PORCELAIN FUSED TO METALInvoclar North America, Inc.Mar 2, 1992SESE
K914627PLATINUM FOIL PLATINUM MILING WAFERMetalor Dental USA Corp.Nov 13, 1991SESE
K913860ULTRACROWN(TM) PD ALLOY POST-SOLDERDentsply Intl.Nov 13, 1991SESE
K913704ARGEBOND 80Argen Precious Metals, Inc.Nov 13, 1991SESE
K913069DW238 #228-04BIvoclar North America, Inc.Oct 2, 1991SESE
K913068DW238 #228-34AIvoclar North America, Inc.Oct 2, 1991SESE
K913070X-L (DW228-14A) AND X-LX (DW228-24A)Ivoclar North America, Inc.Sep 13, 1991SESE
K913232ULTRACROWN(TM) PD DENTAL ALLOYDentsply Intl.Sep 6, 1991SESE
K912493DEGUBOND LITEDegussa AGAug 20, 1991SESE
K911674CERAPLUSMetalor Dental USA Corp.Aug 16, 1991SESE
K911669CERAPALL 6Metalor Dental USA Corp.Aug 16, 1991SESE
K912308STANDARD S32Metalor Dental USA Corp.Aug 9, 1991SESE
K912307STANDARD S31Metalor Dental USA Corp.Aug 9, 1991SESE
K912305STANDARD S3Metalor Dental USA Corp.Aug 9, 1991SESE
K912302VACU 2Metalor Dental USA Corp.Aug 9, 1991SESE
K912195PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USEJelenko Co.Jul 30, 1991SESE
K912194PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USEJelenko Co.Jul 30, 1991SESE
K911671CERADELTAMetalor Dental USA Corp.Jul 10, 1991SESE
K912315V-DELTA S1Metalor Dental USA Corp.Jul 2, 1991SESE
K912314800 SOLDERMetalor Dental USA Corp.Jul 2, 1991SESE
K911545V-DELTAMetalor Dental USA Corp.Jul 2, 1991SESE
K911677SELECTOR 3Metalor Dental USA Corp.Jun 27, 1991SESE
K911675PAGALIN 2Metalor Dental USA Corp.Jun 27, 1991SESE
K911668CERAPALL 2Metalor Dental USA Corp.Jun 27, 1991SESE
K912309STANDARD S33Metalor Dental USA Corp.Jun 26, 1991SESE
K912306STANDARD S4Metalor Dental USA Corp.Jun 26, 1991SESE
K912304STANDARD S2Metalor Dental USA Corp.Jun 26, 1991SESE
K912303STANDARD S1Metalor Dental USA Corp.Jun 26, 1991SESE
K912300VS11Metalor Dental USA Corp.Jun 26, 1991SESE
K912299VS1BMetalor Dental USA Corp.Jun 26, 1991SESE
K912298VS1Metalor Dental USA Corp.Jun 26, 1991SESE
K911757MAXIBONDArgen Precious Metals, Inc.Jun 18, 1991SESE
K911670CERAPALLMetalor Dental USA Corp.Jun 18, 1991SESE
K910467ARGIPLUSArgen Precious Metals, Inc.Apr 30, 1991SESE
K904876DW237Ivoclar North America, Inc.Apr 17, 1991SESE
K903971ARGENCO 26BArgen Precious Metals, Inc.Dec 17, 1990SESE
K903060ARGENCO 34Argen Precious Metals, Inc.Aug 13, 1990SESE
K903009ARGENCO IIIArgen Precious Metals, Inc.Aug 13, 1990SESE
K902665ARGENCO Y (TYPE III/IV DENTAL ALLOY CROWN/BRIDGEArgen Precious Metals, Inc.Aug 7, 1990SESE
K902376DW231 DENTAL ALLOYIvoclar North America, Inc.Jun 28, 1990SESE
K901099PROTOCOL (ALLOY)Ivoclar North America, Inc.Apr 25, 1990SESE
K890811RX APF (CASTING ALLOY)Jeneric/Pentron, Inc.Mar 17, 1989SESE
K883511ALBABOND EDegussa Dental, Inc.Oct 6, 1988SESE
K883509HERAEUS DG 63Degussa Dental, Inc.Sep 22, 1988SESE
K883510DEGUPAL 4Degussa Dental, Inc.Sep 15, 1988SESE
K883507HERAEUS C SPECIALDegussa Dental, Inc.Sep 15, 1988SESE
K883512HERAEUS WHITEDegussa Dental, Inc.Sep 6, 1988SESE
K874821LUNAR CASTING ALLOY FOR PORCELAIN-FUSED-TO-METALDeringer-Ney, Inc.Feb 8, 1988SESE
K873373SINTERLOYDenpac Corp.Oct 27, 1987SESE
K871288GDC 1830 CASTING ALLOYDeringer-Ney, Inc.Apr 15, 1987SESE
K864162DEGUPALDegussa Dental, Inc.Nov 3, 1986SESE
K862856PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTORAustenal Dental, Inc.Aug 26, 1986SESE
K860964WHITE SILVER SOLDER AND YELLOW SILVER SOLDERAustenal Dental, Inc.Mar 26, 1986SESE
K855182ALLOY FOR METAL CROWN & BRIDGE YELLOW PD #46 & #65Williams Gold Refining Co., Inc.Mar 25, 1986SESE
K860439DW217 #18 CROWN/BRIDGE & DW218 #24 CERAMIC ALLOYSWilliams Gold Refining Co., Inc.Mar 20, 1986SESE
K860299REALOR ALLOYDegussa Dental, Inc.Mar 17, 1986SESE
K860119GDC 1742 (A CASTING ALLOY FOR DENTAL RESTORATIONS)Deringer-Ney, Inc.Mar 17, 1986SESE
K852093ALLOY 7Williams Gold Refining Co., Inc.Aug 23, 1985SESE
K852347DENTAL CASTING ALLOY GDC 1686Deringer-Ney, Inc.Jul 31, 1985SESE
K851648HERACOR SYSTEM HERACOR PLATINUM FOIL, BLENDGOLD NEHeraeus Dental Gold Corp.Jun 4, 1985SESE
K850699SPARTAN -ALLOY FOR PORCELAIN FUSED TO METALWilliams Gold Refining Co., Inc.Mar 18, 1985SESE
K850193PORS-ON HF-SOLDER(PORCELAIN DENTAL ALLOYS)Degussa Dental, Inc.Feb 8, 1985SESE
K850103GDC-1489 A CASTING ALLOYDeringer-Ney, Inc.Feb 8, 1985SESE
K850102GDC-1433 A CASTING ALLOYDeringer-Ney, Inc.Feb 8, 1985SESE
K850101GDC-1629 A CASTING ALLOYDeringer-Ney, Inc.Feb 8, 1985SESE
K840563RX C & B 20Jeneric Ind.May 1, 1984SESE
K840561RX ELANJeneric Ind.May 1, 1984SESE
K840014CHEMODENT CERAMIC METALChemodent Metal Co.Mar 30, 1984SESE
K833774NATURELLE II & LITE II-N72-N74-LJeneric Ind.Jan 24, 1984SESE
K833596GDC 1448 DEVELOPMENT NAMEDeringer-Ney, Inc.Dec 29, 1983SESE
K833434CERAMCO * HIGH FUSING FOIL SOLDERJohnson & Johnson Professionals, Inc.Dec 29, 1983SESE
K833445DEGUPLUS 2Degussa Dental, Inc.Dec 26, 1983SESE
K833050RX 90Jeneric Ind.Oct 28, 1983SESE
K833049PALLADENTJeneric Ind.Oct 28, 1983SESE
K832425GREAT LAKES PASTE SOLDERGreat Lakes Orthodontics, Ltd.Oct 4, 1983SESE
K832530DEVA 4Degussa Dental, Inc.Sep 29, 1983SESE
K832253X-704Unitek Corp.Aug 31, 1983SESE
K831097CONCERTOUnitek Corp.Jun 15, 1983SESE
K831096STROMA IIUnitek Corp.Jun 15, 1983SESE
K823100RX 91Bauer, Cheng & Associates, Inc.Nov 10, 1982SESE
K823097NATURELLEBauer, Cheng & Associates, Inc.Nov 10, 1982SESE
K823084CHALLENGERBauer, Cheng & Associates, Inc.Nov 10, 1982SESE
K822950RX UNIVERSALJeneric Ind.Oct 22, 1982SESE
K822419NEW CROWN AND BRIDGE ALLOY NO. DW196Williams Gold Refining Co., Inc.Aug 30, 1982SESE
K82179882 ALLOYJ. Aderer, Inc.Jul 13, 1982SESE
K821832DEGUCAST UJ. Aderer, Inc.Jul 6, 1982SESE
K821590PORS-ONJ. Aderer, Inc.Jun 14, 1982SESE
K821572DUALLOR 'R'J. Aderer, Inc.Jun 14, 1982SESE
K821510A THENIUMWilliams Gold Refining Co., Inc.Jun 9, 1982SESE
K821407DEVA MJ. Aderer, Inc.Jun 9, 1982SESE
K821299CER-MATEJ. Aderer, Inc.May 28, 1982SESE
K821022PRECIOUS METAL ALLOYSJ. Aderer, Inc.May 10, 1982SESE
K820955BOND-ONJ. Aderer, Inc.May 5, 1982SESE
K820530T-IV ELITE ALLOYHowmedica Corp.Mar 19, 1982SESE
K820434CLASS OF CASTING ALLOYS TYPE III OR ALTHowmedica Corp.Mar 11, 1982SESE
K820433CLASS OF CASTING ALLOYS TYPE II OR ALTERHowmedica Corp.Mar 11, 1982SESE
K820432CLASS OF CASTING ALLOYS TYPE I OR ALTERHowmedica Corp.Mar 11, 1982SESE
K820408CLASS OF CASTING ALLOYS TYPE IV OR ALTHowmedica Corp.Mar 2, 1982SESE
K820407CLASS OF PRECIOUS METAL CASTING ALLOYSHowmedica Corp.Mar 2, 1982SESE
K813418INZOMA NPJ. Aderer, Inc.Jan 7, 1982SESE
K813200GDC-1136 CASTING ALLOY FOR PORCELAIN-FUNeyDec 31, 1981SESE
K812101BAK-ON SP PORCELAIN ALLOYJohnson & Johnson Professionals, Inc.Aug 18, 1981SESE
K811563PRESOLDER FOR NON-PRECIOUS DENTAL ALLOYSWilliams Gold Refining Co., Inc.Jul 28, 1981SESE
K810380HOWMEDICA T-III G ALLOYHowmedica Corp.Mar 17, 1981SESE
K801277GDC 934Deringer-Ney, Inc.Jul 21, 1980SESE
K801009HOWMEDICA WHITE C&B ALLOYDental Laboratory Products Div.Jun 4, 1980SESE
K800951CASTA-LLOYU.S. Shizai Corp.May 8, 1980SESE
K800994AUSTRY ALLOY(DENTAL BAKE-ON ALLOY)Howmedica Corp.May 2, 1980SESE
K792274TEMPODeringer-Ney, Inc.Nov 30, 1979SESE
K792008HOWMEDICA AG-PD CROWN AND BRIDGE ALLOYHowmedica Corp.Nov 20, 1979SESE
K791973HOWMEDICA A-35 DENTAL ALLOYHowmedica Corp.Nov 20, 1979SESE
K791005CHEMODENT CERAMIC METALChemodent Dental LaboratoryAug 10, 1979SESE
K790641GDC-685Deringer-Ney, Inc.May 1, 1979SESE
K790097SALIVAN & SALIVAN BROWNDen-Mat Corp.Feb 26, 1979SESE
K790096SALIVAN PARAEIGHT TOUGHNESSDen-Mat Corp.Feb 26, 1979SESE
K771596WILL-CERAM W-3Williams Gold Refining Co., Inc.Aug 26, 1977SESE
K771145WILL-CERAM W-2Williams Gold Refining Co., Inc.Jul 15, 1977SESE
K760783BIOBOND-CROWN & BRIDGE CERAMIC BONDINGDentsply Intl.Oct 15, 1976SESE
K760379DENTAL AMALGAM ALLOY (SPHERICAL II)L.D. Caulk Co.Aug 23, 1976SESE

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