EJS
194 FDA 510(k) clearances · Product code
53 daysmedian time to decision
90 days90th percentile
194clearances measured
FDA profile
- Official device name
- Alloy, Other Noble Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3060
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2004: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BRIGHT GOLD XH (K041433) | Ivoclar Vivadent, Inc. | 2004-08-19 |
| SIMIDUR SUPERIOR (K040436) | Wieland Dental + Technik GmbH & Co. KG | 2004-03-05 |
| STERNGOLD 1, MODEL 1127781 (K022252) | Sterngold | 2002-09-19 |
| ECO E4 (K022469) | Wieland Dental + Technik GmbH & Co. KG | 2002-09-18 |
| STERNGOLD 66, MODEL #1180230 (K021367) | Sterngold | 2002-05-16 |
| SIMIDUR S1S (K020195) | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 |
| SIMIDUR S2 (K020192) | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 |
| SIMIDUR KF PLUS (K020194) | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 |
| D.SIGN 84 (K014042) | Ivoclar Vivadent, Inc. | 2002-02-22 |
| D.SIGN 59 (K013809) | Ivoclar Vivadent, Inc. | 2002-02-07 |
| D.SIGN 53, MODEL NA1012204 (K014082) | Ivoclar Vivadent, Inc. | 2002-01-30 |
| DUO PAL 6, ORDER-NO.: 2154 (K012841) | Wieland Edelmetalle GmbH & Co. | 2001-11-20 |
| PORTA SMK 82, MODEL 2032 (K012828) | Wieland Edelmetalle GmbH & Co. | 2001-11-01 |
| EURO 45, ORDER-NO.: 2064 (K012840) | Wieland Edelmetalle GmbH & Co. | 2001-10-23 |
| JEL-20 (K012303) | J.F. Jelenko & Co., Inc. | 2001-08-22 |
| DW 273 #1 (K003632) | Ivoclar North America, Inc. | 2000-12-20 |
| R&D PROJECT DW269#25 (K001469) | Ivoclar North America, Inc. | 2000-07-05 |
| JEL 15 (K000532) | J.F. Jelenko & Co., Inc. | 2000-04-06 |
| AUROFLUID M, ALLOY NO. 5315 (K993475) | Metalor Dental USA Corp. | 1999-12-09 |
| PAGALINOR 4 , ALLOY NO. 5440 (K993506) | Metalor Dental USA Corp. | 1999-12-08 |
| V-DELTA SPECIAL, ALLOY NO. 5154 (K993505) | Metalor Dental USA Corp. | 1999-12-08 |
| DELTAPAL, ALLOY NO. 5161 (K993474) | Metalor Dental USA Corp. | 1999-12-02 |
| ALLROUND-E (CODE NAME RD 1710) (K984587) | J.F. Jelenko & Co., Inc. | 1999-03-17 |
| D-SIGN III (R&D PROJECT DW264#7) (K990077) | Ivoclar North America, Inc. | 1999-02-12 |
| D-SIGN IV (R&D PROJECT DW265#37) (K990078) | Ivoclar North America, Inc. | 1999-02-12 |
| D-SIGN I (R&D PROJECT DW263 #24) (K984451) | Ivoclar North America, Inc. | 1999-01-19 |
| BEGOPAL 300 (K983081) | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | 1998-10-28 |
| BEGOPAL (K983078) | Bego U.S.A. | 1998-10-23 |
| JELFINE-52 (CODE NAME RD-0901) (K981257) | J.F. Jelenko & Co., Inc. | 1998-08-13 |
| SILCAST (CODE NAME RD-0118) (K981247) | J.F. Jelenko & Co., Inc. | 1998-07-01 |
| ORION WX DENTAL ALLOY (K981002) | European Dental Imports, Inc. | 1998-05-18 |
| ORION VESTA DENTAL ALLOY (K981001) | European Dental Imports, Inc. | 1998-05-18 |
| CERA E DENTAL ALLOY (K980661) | European Dental Imports, Inc. | 1998-05-01 |
| AURENORM 68 (K972945) | Aurex Precious Metal Industries (Pty)Ltd | 1997-11-26 |
| STABILOR HN (K973288) | Degussa Corp. | 1997-11-19 |
| VERA SOLDER (K972533) | Aalba Dent, Inc. | 1997-09-05 |
| ALFALLOY (K972534) | Aalba Dent, Inc. | 1997-09-05 |
| V-DELTA 450 (K972683) | Metalor Dental USA Corp. | 1997-08-18 |
| SOLARO 33 (K970045) | Metalor Dental USA Corp. | 1997-03-05 |
| AUROFLUID 22 (K970044) | Metalor Dental USA Corp. | 1997-03-05 |
| SOLDER 585 (K964707) | Gateway Alloys, Inc. | 1996-12-16 |
| SOLDER GPW (K964713) | Gateway Alloys, Inc. | 1996-12-16 |
| SOLDER 650 (K964706) | Gateway Alloys, Inc. | 1996-12-16 |
| SOLDER GPY (K964705) | Gateway Alloys, Inc. | 1996-12-16 |
| STERNGOLD U-CPF METAL ALLOY (1067800) (K962324) | Sterngold/Implamed | 1996-07-24 |
| STERNGOLD BIO-4 (K962304) | Sterngold/Implamed | 1996-07-23 |
| STERNGOLD G-HARD METAL ALLOY (K962301) | The Stern Metals Co., Inc. | 1996-07-18 |
| DW234 #29 (K941625) | Rms Div. | 1994-06-22 |
| CU-FREE & LTA (K934757) | Jeneric/Pentron, Inc. | 1994-02-04 |
| CERAPALL 4CF (K935388) | Metalor | 1994-01-06 |
| ARGELITE A (K934773) | Argen Precious Metals, Inc. | 1993-12-10 |
| VS 1A (K933563) | Metalor Dental USA Corp. | 1993-10-20 |
| BIO C & B (K926146) | Jeneric/Pentron, Inc. | 1993-05-27 |
| GOLD-PLATINUM BASED CASTING ALLOY (K926147) | Jeneric/Pentron, Inc. | 1993-05-27 |
| CORRECT AND CORRECT FIT II (K925331) | Jeneric/Pentron, Inc. | 1993-05-27 |
| NUGOLD 2% (K926145) | Jeneric/Pentron, Inc. | 1993-05-05 |
| CERAPALL 6 -- MODIFIED (K924292) | Metalor Dental USA Corp. | 1993-03-01 |
| KB58-KF (K922958) | Jeneric/Pentron, Inc. | 1993-02-26 |
| ZENON PLUS (K922955) | Jeneric/Pentron, Inc. | 1992-12-23 |
| GDC 3445 (K925273) | Deringer-Ney, Inc. | 1992-12-21 |
| DW243-64 (K923644) | Ivoclar USA, Inc. | 1992-11-04 |
| KB40-KF (K922956) | Jeneric/Pentron, Inc. | 1992-09-14 |
| PARAGON (K922957) | Jeneric/Pentron, Inc. | 1992-09-14 |
| PA-400 (K922449) | J.F. Jelenko & Co., Inc. | 1992-08-05 |
| BENCHMARK III (K922447) | J.F. Jelenko & Co., Inc. | 1992-08-05 |
| BENCHMARK C (K922450) | J.F. Jelenko & Co., Inc. | 1992-08-05 |
| BENCHMARK I (K922448) | J.F. Jelenko & Co., Inc. | 1992-08-05 |
| ACCU-STAR (K922446) | J.F. Jelenko & Co., Inc. | 1992-08-05 |
| LEGACY-XT (K922451) | J.F. Jelenko & Co., Inc. | 1992-08-05 |
| DEGUBOND PLUS (K921445) | Degussa AG | 1992-05-26 |
| DEVA PLUS (K921419) | Degussa AG | 1992-05-26 |
| GDC 3367 (K920922) | Deringer-Ney, Inc. | 1992-05-05 |
| DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL (K920613) | Ivoclar North America, Inc. | 1992-04-21 |
| ARGEBOND 77+ (K915165) | Argen Precious Metals, Inc. | 1992-04-21 |
| GDC-3338, DENTAL SOLDER ALLOY (K920887) | Deringer-Ney, Inc. | 1992-03-19 |
| DW236-34 ALLOY FOR PORCELAIN FUSED TO METAL (K920560) | Invoclar North America, Inc. | 1992-03-02 |
| PLATINUM FOIL PLATINUM MILING WAFER (K914627) | Metalor Dental USA Corp. | 1991-11-13 |
| ULTRACROWN(TM) PD ALLOY POST-SOLDER (K913860) | Dentsply Intl. | 1991-11-13 |
| ARGEBOND 80 (K913704) | Argen Precious Metals, Inc. | 1991-11-13 |
| DW238 #228-34A (K913068) | Ivoclar North America, Inc. | 1991-10-02 |
| DW238 #228-04B (K913069) | Ivoclar North America, Inc. | 1991-10-02 |
| X-L (DW228-14A) AND X-LX (DW228-24A) (K913070) | Ivoclar North America, Inc. | 1991-09-13 |
| ULTRACROWN(TM) PD DENTAL ALLOY (K913232) | Dentsply Intl. | 1991-09-06 |
| DEGUBOND LITE (K912493) | Degussa AG | 1991-08-20 |
| CERAPLUS (K911674) | Metalor Dental USA Corp. | 1991-08-16 |
| CERAPALL 6 (K911669) | Metalor Dental USA Corp. | 1991-08-16 |
| STANDARD S3 (K912305) | Metalor Dental USA Corp. | 1991-08-09 |
| STANDARD S31 (K912307) | Metalor Dental USA Corp. | 1991-08-09 |
| VACU 2 (K912302) | Metalor Dental USA Corp. | 1991-08-09 |
| STANDARD S32 (K912308) | Metalor Dental USA Corp. | 1991-08-09 |
| PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE (K912195) | Jelenko Co. | 1991-07-30 |
| PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE (K912194) | Jelenko Co. | 1991-07-30 |
| CERADELTA (K911671) | Metalor Dental USA Corp. | 1991-07-10 |
| V-DELTA (K911545) | Metalor Dental USA Corp. | 1991-07-02 |
| 800 SOLDER (K912314) | Metalor Dental USA Corp. | 1991-07-02 |
| V-DELTA S1 (K912315) | Metalor Dental USA Corp. | 1991-07-02 |
| SELECTOR 3 (K911677) | Metalor Dental USA Corp. | 1991-06-27 |
| PAGALIN 2 (K911675) | Metalor Dental USA Corp. | 1991-06-27 |
| CERAPALL 2 (K911668) | Metalor Dental USA Corp. | 1991-06-27 |
| VS1B (K912299) | Metalor Dental USA Corp. | 1991-06-26 |
Track EJS automatically
Every clearance here is in the API, with alerts when new ones post.