FDA Product Code
FDA Product Code EJS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3060
510(k) Clearances — 194 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K041433 | BRIGHT GOLD XH | Ivoclar Vivadent, Inc. | 2004-08-19 | Traditional | PDF ↗ |
| K040436 | SIMIDUR SUPERIOR | Wieland Dental + Technik GmbH & Co. KG | 2004-03-05 | Traditional | PDF ↗ |
| K022252 | STERNGOLD 1, MODEL 1127781 | Sterngold | 2002-09-19 | Abbreviated | PDF ↗ |
| K022469 | ECO E4 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-18 | Traditional | PDF ↗ |
| K021367 | STERNGOLD 66, MODEL #1180230 | Sterngold | 2002-05-16 | Abbreviated | PDF ↗ |
| K020195 | SIMIDUR S1S | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 | Traditional | PDF ↗ |
| K020192 | SIMIDUR S2 | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 | Traditional | PDF ↗ |
| K020194 | SIMIDUR KF PLUS | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 | Traditional | PDF ↗ |
| K014042 | D.SIGN 84 | Ivoclar Vivadent, Inc. | 2002-02-22 | Traditional | PDF ↗ |
| K013809 | D.SIGN 59 | Ivoclar Vivadent, Inc. | 2002-02-07 | Traditional | PDF ↗ |
| K014082 | D.SIGN 53, MODEL NA1012204 | Ivoclar Vivadent, Inc. | 2002-01-30 | Traditional | PDF ↗ |
| K012841 | DUO PAL 6, ORDER-NO.: 2154 | Wieland Edelmetalle GmbH & Co. | 2001-11-20 | Traditional | PDF ↗ |
| K012828 | PORTA SMK 82, MODEL 2032 | Wieland Edelmetalle GmbH & Co. | 2001-11-01 | Traditional | PDF ↗ |
| K012840 | EURO 45, ORDER-NO.: 2064 | Wieland Edelmetalle GmbH & Co. | 2001-10-23 | Traditional | PDF ↗ |
| K012303 | JEL-20 | J.F. Jelenko & Co., Inc. | 2001-08-22 | Traditional | PDF ↗ |
| K003632 | DW 273 #1 | Ivoclar North America, Inc. | 2000-12-20 | Traditional | PDF ↗ |
| K001469 | R&D PROJECT DW269#25 | Ivoclar North America, Inc. | 2000-07-05 | Traditional | PDF ↗ |
| K000532 | JEL 15 | J.F. Jelenko & Co., Inc. | 2000-04-06 | Traditional | PDF ↗ |
| K993475 | AUROFLUID M, ALLOY NO. 5315 | Metalor Dental USA Corp. | 1999-12-09 | Traditional | PDF ↗ |
| K993505 | V-DELTA SPECIAL, ALLOY NO. 5154 | Metalor Dental USA Corp. | 1999-12-08 | Traditional | PDF ↗ |
| K993506 | PAGALINOR 4 , ALLOY NO. 5440 | Metalor Dental USA Corp. | 1999-12-08 | Traditional | PDF ↗ |
| K993474 | DELTAPAL, ALLOY NO. 5161 | Metalor Dental USA Corp. | 1999-12-02 | Traditional | PDF ↗ |
| K984587 | ALLROUND-E (CODE NAME RD 1710) | J.F. Jelenko & Co., Inc. | 1999-03-17 | Traditional | PDF ↗ |
| K990078 | D-SIGN IV (R&D PROJECT DW265#37) | Ivoclar North America, Inc. | 1999-02-12 | Traditional | PDF ↗ |
| K990077 | D-SIGN III (R&D PROJECT DW264#7) | Ivoclar North America, Inc. | 1999-02-12 | Traditional | PDF ↗ |
| K984451 | D-SIGN I (R&D PROJECT DW263 #24) | Ivoclar North America, Inc. | 1999-01-19 | Traditional | PDF ↗ |
| K983081 | BEGOPAL 300 | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | 1998-10-28 | Traditional | PDF ↗ |
| K983078 | BEGOPAL | Bego U.S.A. | 1998-10-23 | Traditional | PDF ↗ |
| K981257 | JELFINE-52 (CODE NAME RD-0901) | J.F. Jelenko & Co., Inc. | 1998-08-13 | Traditional | PDF ↗ |
| K981247 | SILCAST (CODE NAME RD-0118) | J.F. Jelenko & Co., Inc. | 1998-07-01 | Traditional | PDF ↗ |
| K981001 | ORION VESTA DENTAL ALLOY | European Dental Imports, Inc. | 1998-05-18 | Traditional | PDF ↗ |
| K981002 | ORION WX DENTAL ALLOY | European Dental Imports, Inc. | 1998-05-18 | Traditional | PDF ↗ |
| K980661 | CERA E DENTAL ALLOY | European Dental Imports, Inc. | 1998-05-01 | Traditional | PDF ↗ |
| K972945 | AURENORM 68 | Aurex Precious Metal Industries (Pty)Ltd | 1997-11-26 | Traditional | PDF ↗ |
| K973288 | STABILOR HN | Degussa Corp. | 1997-11-19 | Traditional | PDF ↗ |
| K972533 | VERA SOLDER | Aalba Dent, Inc. | 1997-09-05 | Traditional | PDF ↗ |
| K972534 | ALFALLOY | Aalba Dent, Inc. | 1997-09-05 | Traditional | PDF ↗ |
| K972683 | V-DELTA 450 | Metalor Dental USA Corp. | 1997-08-18 | Traditional | PDF ↗ |
| K970044 | AUROFLUID 22 | Metalor Dental USA Corp. | 1997-03-05 | Traditional | PDF ↗ |
| K970045 | SOLARO 33 | Metalor Dental USA Corp. | 1997-03-05 | Traditional | PDF ↗ |
| K964707 | SOLDER 585 | Gateway Alloys, Inc. | 1996-12-16 | Traditional | PDF ↗ |
| K964713 | SOLDER GPW | Gateway Alloys, Inc. | 1996-12-16 | Traditional | PDF ↗ |
| K964706 | SOLDER 650 | Gateway Alloys, Inc. | 1996-12-16 | Traditional | PDF ↗ |
| K964705 | SOLDER GPY | Gateway Alloys, Inc. | 1996-12-16 | Traditional | PDF ↗ |
| K962324 | STERNGOLD U-CPF METAL ALLOY (1067800) | Sterngold/Implamed | 1996-07-24 | Traditional | PDF ↗ |
| K962304 | STERNGOLD BIO-4 | Sterngold/Implamed | 1996-07-23 | Traditional | PDF ↗ |
| K962301 | STERNGOLD G-HARD METAL ALLOY | The Stern Metals Co., Inc. | 1996-07-18 | Traditional | PDF ↗ |
| K941625 | DW234 #29 | Rms Div. | 1994-06-22 | Traditional | PDF ↗ |
| K934757 | CU-FREE & LTA | Jeneric/Pentron, Inc. | 1994-02-04 | Traditional | PDF ↗ |
| K935388 | CERAPALL 4CF | Metalor | 1994-01-06 | Traditional | PDF ↗ |
| K934773 | ARGELITE A | Argen Precious Metals, Inc. | 1993-12-10 | Traditional | PDF ↗ |
| K933563 | VS 1A | Metalor Dental USA Corp. | 1993-10-20 | Traditional | PDF ↗ |
| K926146 | BIO C & B | Jeneric/Pentron, Inc. | 1993-05-27 | Traditional | PDF ↗ |
| K925331 | CORRECT AND CORRECT FIT II | Jeneric/Pentron, Inc. | 1993-05-27 | Traditional | PDF ↗ |
| K926147 | GOLD-PLATINUM BASED CASTING ALLOY | Jeneric/Pentron, Inc. | 1993-05-27 | Traditional | PDF ↗ |
| K926145 | NUGOLD 2% | Jeneric/Pentron, Inc. | 1993-05-05 | Traditional | PDF ↗ |
| K924292 | CERAPALL 6 -- MODIFIED | Metalor Dental USA Corp. | 1993-03-01 | Traditional | PDF ↗ |
| K922958 | KB58-KF | Jeneric/Pentron, Inc. | 1993-02-26 | Traditional | PDF ↗ |
| K922955 | ZENON PLUS | Jeneric/Pentron, Inc. | 1992-12-23 | Traditional | PDF ↗ |
| K925273 | GDC 3445 | Deringer-Ney, Inc. | 1992-12-21 | Traditional | PDF ↗ |
| K923644 | DW243-64 | Ivoclar USA, Inc. | 1992-11-04 | Traditional | PDF ↗ |
| K922956 | KB40-KF | Jeneric/Pentron, Inc. | 1992-09-14 | Traditional | PDF ↗ |
| K922957 | PARAGON | Jeneric/Pentron, Inc. | 1992-09-14 | Traditional | PDF ↗ |
| K922446 | ACCU-STAR | J.F. Jelenko & Co., Inc. | 1992-08-05 | Traditional | PDF ↗ |
| K922448 | BENCHMARK I | J.F. Jelenko & Co., Inc. | 1992-08-05 | Traditional | PDF ↗ |
| K922447 | BENCHMARK III | J.F. Jelenko & Co., Inc. | 1992-08-05 | Traditional | PDF ↗ |
| K922450 | BENCHMARK C | J.F. Jelenko & Co., Inc. | 1992-08-05 | Traditional | PDF ↗ |
| K922449 | PA-400 | J.F. Jelenko & Co., Inc. | 1992-08-05 | Traditional | PDF ↗ |
| K922451 | LEGACY-XT | J.F. Jelenko & Co., Inc. | 1992-08-05 | Traditional | PDF ↗ |
| K921445 | DEGUBOND PLUS | Degussa AG | 1992-05-26 | Traditional | PDF ↗ |
| K921419 | DEVA PLUS | Degussa AG | 1992-05-26 | Traditional | PDF ↗ |
| K920922 | GDC 3367 | Deringer-Ney, Inc. | 1992-05-05 | Traditional | PDF ↗ |
| K915165 | ARGEBOND 77+ | Argen Precious Metals, Inc. | 1992-04-21 | Traditional | PDF ↗ |
| K920613 | DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL | Ivoclar North America, Inc. | 1992-04-21 | Traditional | PDF ↗ |
| K920887 | GDC-3338, DENTAL SOLDER ALLOY | Deringer-Ney, Inc. | 1992-03-19 | Traditional | PDF ↗ |
| K920560 | DW236-34 ALLOY FOR PORCELAIN FUSED TO METAL | Invoclar North America, Inc. | 1992-03-02 | Traditional | PDF ↗ |
| K913860 | ULTRACROWN(TM) PD ALLOY POST-SOLDER | Dentsply Intl. | 1991-11-13 | Traditional | PDF ↗ |
| K914627 | PLATINUM FOIL PLATINUM MILING WAFER | Metalor Dental USA Corp. | 1991-11-13 | Traditional | PDF ↗ |
| K913704 | ARGEBOND 80 | Argen Precious Metals, Inc. | 1991-11-13 | Traditional | PDF ↗ |
| K913068 | DW238 #228-34A | Ivoclar North America, Inc. | 1991-10-02 | Traditional | PDF ↗ |
| K913069 | DW238 #228-04B | Ivoclar North America, Inc. | 1991-10-02 | Traditional | PDF ↗ |
| K913070 | X-L (DW228-14A) AND X-LX (DW228-24A) | Ivoclar North America, Inc. | 1991-09-13 | Traditional | PDF ↗ |
| K913232 | ULTRACROWN(TM) PD DENTAL ALLOY | Dentsply Intl. | 1991-09-06 | Traditional | PDF ↗ |
| K912493 | DEGUBOND LITE | Degussa AG | 1991-08-20 | Traditional | PDF ↗ |
| K911674 | CERAPLUS | Metalor Dental USA Corp. | 1991-08-16 | Traditional | PDF ↗ |
| K911669 | CERAPALL 6 | Metalor Dental USA Corp. | 1991-08-16 | Traditional | PDF ↗ |
| K912308 | STANDARD S32 | Metalor Dental USA Corp. | 1991-08-09 | Traditional | PDF ↗ |
| K912307 | STANDARD S31 | Metalor Dental USA Corp. | 1991-08-09 | Traditional | PDF ↗ |
| K912305 | STANDARD S3 | Metalor Dental USA Corp. | 1991-08-09 | Traditional | PDF ↗ |
| K912302 | VACU 2 | Metalor Dental USA Corp. | 1991-08-09 | Traditional | PDF ↗ |
| K912194 | PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE | Jelenko Co. | 1991-07-30 | Traditional | PDF ↗ |
| K912195 | PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE | Jelenko Co. | 1991-07-30 | Traditional | PDF ↗ |
| K911671 | CERADELTA | Metalor Dental USA Corp. | 1991-07-10 | Traditional | PDF ↗ |
| K912315 | V-DELTA S1 | Metalor Dental USA Corp. | 1991-07-02 | Traditional | PDF ↗ |
| K911545 | V-DELTA | Metalor Dental USA Corp. | 1991-07-02 | Traditional | PDF ↗ |
| K912314 | 800 SOLDER | Metalor Dental USA Corp. | 1991-07-02 | Traditional | PDF ↗ |
| K911675 | PAGALIN 2 | Metalor Dental USA Corp. | 1991-06-27 | Traditional | PDF ↗ |
| K911668 | CERAPALL 2 | Metalor Dental USA Corp. | 1991-06-27 | Traditional | PDF ↗ |
| K911677 | SELECTOR 3 | Metalor Dental USA Corp. | 1991-06-27 | Traditional | PDF ↗ |
| K912306 | STANDARD S4 | Metalor Dental USA Corp. | 1991-06-26 | Traditional | PDF ↗ |
Product code EJS · Class II · Dental. Data: openFDA.