FDA Product Code
FDA Product Code EJT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3060
510(k) Clearances — 627 records · page 2 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K003634 | DW 272 #1 | Ivoclar North America, Inc. | 2000-12-21 | Traditional | PDF ↗ |
| K003633 | DW 277 #4 | Ivoclar North America, Inc. | 2000-12-20 | Traditional | PDF ↗ |
| K002854 | GOLD CORE POST SOLDER | Jeneric/Pentron, Inc. | 2000-12-20 | Traditional | PDF ↗ |
| K002815 | GOLD CORE HF PRE SOLDER | Jeneric/Pentron, Inc. | 2000-12-19 | Traditional | PDF ↗ |
| K003007 | GALAXY | Sterngold | 2000-11-17 | Abbreviated | PDF ↗ |
| K002872 | R&D PROJECT DW271#11A | Ivoclar North America, Inc. | 2000-11-02 | Traditional | PDF ↗ |
| K002675 | MILLENNIUM EDITION 2000 ACCELERATED ELECTROFORMING SYSTEM | Product Development Industries, Inc. | 2000-10-25 | Traditional | PDF ↗ |
| K002826 | EQUITY | Jensen Industries, Inc. | 2000-10-24 | Abbreviated | PDF ↗ |
| K002645 | JEL BIOS PURE | J.F. Jelenko & Co., Inc. | 2000-10-19 | Traditional | PDF ↗ |
| K002222 | RD-2104 | J.F. Jelenko & Co., Inc. | 2000-08-31 | Traditional | PDF ↗ |
| K001481 | PALCERAM 49 | Aurex SA (Pty) , Ltd. | 2000-06-23 | Traditional | PDF ↗ |
| K001482 | AURENORM 75 KF | Aurex SA (Pty) , Ltd. | 2000-06-23 | Traditional | PDF ↗ |
| K001479 | PALCERAM 53 | Aurex SA (Pty) , Ltd. | 2000-06-21 | Traditional | PDF ↗ |
| K001480 | AURECAST 40 B | Aurex SA (Pty) , Ltd. | 2000-06-21 | Traditional | PDF ↗ |
| K001477 | AURELUX Y 84 PREMIUM | Aurex SA (Pty) , Ltd. | 2000-06-20 | Traditional | PDF ↗ |
| K001478 | AURECAST SUPER INLAY | Aurex SA (Pty) , Ltd. | 2000-06-20 | Traditional | PDF ↗ |
| K001041 | AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD | Wieland Edelmetalle GmbH & Co. | 2000-05-23 | Traditional | PDF ↗ |
| K001260 | ALLROUND 55 LF | J.F. Jelenko & Co., Inc. | 2000-05-17 | Traditional | PDF ↗ |
| K001196 | JEL BIOS 90 (CODE NAME RD-2401) | J.F. Jelenko & Co., Inc. | 2000-05-11 | Traditional | PDF ↗ |
| K001051 | RX EVEREST | Jeneric/Pentron, Inc. | 2000-04-28 | Traditional | PDF ↗ |
| K000360 | RX G-UNIVERSAL | Jeneric/Pentron, Inc. | 2000-02-18 | Traditional | PDF ↗ |
| K993508 | V-SUPRA PLUS, ALLOY NO. 5025 | Metalor Dental USA Corp. | 1999-12-06 | Traditional | PDF ↗ |
| K993507 | V-SUPRAGOLD, ALLOY NO. 5024 | Metalor Dental USA Corp. | 1999-12-06 | Traditional | PDF ↗ |
| K993173 | GOLD CORE 55 | Jeneric/Pentron, Inc. | 1999-10-26 | Traditional | PDF ↗ |
| K993175 | GOLD CORE 75 | Jeneric/Pentron, Inc. | 1999-10-26 | Traditional | PDF ↗ |
| K993152 | JEL BIOS 18 (CODE NAME RD- 1214) | J.F. Jelenko & Co., Inc. | 1999-10-21 | Traditional | PDF ↗ |
| K993136 | JEL BIOS 10 (CODE NAME RD-1801) | J.F. Jelenko & Co., Inc. | 1999-10-21 | Traditional | PDF ↗ |
| K991901 | BIO-97 | Jeneric/Pentron, Inc. | 1999-09-07 | Traditional | PDF ↗ |
| K990670 | HELIOFORM GOLD-BASED ALLOY | C. Hafner GmbH & Co. | 1999-04-02 | Traditional | PDF ↗ |
| K984140 | MAINBOND A | J.F. Jelenko & Co., Inc. | 1999-01-13 | Traditional | PDF ↗ |
| K983082 | BEGOCER G | Bego U.S.A. | 1998-10-28 | Traditional | PDF ↗ |
| K983080 | AUROLLOYD KF | Bego U.S.A. | 1998-10-28 | Traditional | PDF ↗ |
| K983079 | PLATINLLOYD 100 | Bego U.S.A. | 1998-10-23 | Traditional | PDF ↗ |
| K983077 | BIO PONTOSTAR | Bego U.S.A. | 1998-10-23 | Traditional | PDF ↗ |
| K982606 | AUROFLUID CPF | Metalor Dental USA Corp. | 1998-10-15 | Traditional | PDF ↗ |
| K981244 | BW-1 (CODE NAME RD-0807) | J.F. Jelenko & Co., Inc. | 1998-08-13 | Traditional | PDF ↗ |
| K980660 | BIOGOLD PLUS DENTAL ALLOY | European Dental Imports, Inc. | 1998-04-27 | Traditional | PDF ↗ |
| K980613 | PROGOLD ELECTROCOPING SYSTEM | Micro Dental Laboratories | 1998-03-09 | Traditional | PDF ↗ |
| K980597 | CARRARA PDF, CARRARA H, CARRARA R | European Dental Imports, Inc. | 1998-03-09 | Traditional | PDF ↗ |
| K972946 | AURELUX 77 | Aurex Precious Metal Industries (Pty)Ltd | 1997-12-19 | Traditional | PDF ↗ |
| K973372 | AUROFILM 2000 | Metalor Dental USA Corp. | 1997-11-26 | Traditional | PDF ↗ |
| K973881 | PROSPECTOR PLUS (CODE NAME : RD-0508) | J.F. Jelenko & Co., Inc. | 1997-11-24 | Traditional | PDF ↗ |
| K972910 | PORS ON LITE | Degussa Corp. | 1997-10-14 | Traditional | PDF ↗ |
| K972949 | AURELUX BIO Y85PF | Aurex Precious Metal Industries (Pty)Ltd | 1997-09-18 | Traditional | PDF ↗ |
| K972943 | AURECAST 92 | Aurex Precious Metal Industries (Pty)Ltd | 1997-09-16 | Traditional | PDF ↗ |
| K972951 | HIPALLAUR 51 | Aurex Precious Metal Industries (Pty)Ltd | 1997-09-05 | Traditional | PDF ↗ |
| K972950 | HIPALLAUR 19 | Aurex Precious Metal Industries (Pty)Ltd | 1997-09-05 | Traditional | PDF ↗ |
| K972954 | PALAUREX 78 | Aurex Precious Metal Industries (Pty)Ltd | 1997-09-05 | Traditional | PDF ↗ |
| K972956 | PALCERAM 82SF | Aurex Precious Metal Industries (Pty)Ltd | 1997-09-05 | Traditional | PDF ↗ |
| K972955 | PALCERAM 56 | Aurex Precious Metal Industries (Pty)Ltd | 1997-09-05 | Traditional | PDF ↗ |
| K972952 | AUREBOND 51 | Aurex Precious Metal Industries (Pty)Ltd | 1997-09-05 | Traditional | PDF ↗ |
| K972953 | PALAUREX 76KF | Aurex Precious Metal Industries (Pty)Ltd | 1997-09-05 | Traditional | PDF ↗ |
| K972941 | AURECAST 74 | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-28 | Traditional | PDF ↗ |
| K972942 | AURECAST 83 | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-28 | Traditional | PDF ↗ |
| K972319 | AURECAST GF | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-26 | Traditional | PDF ↗ |
| K972940 | AURECAST BIO 69PF | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-26 | Traditional | PDF ↗ |
| K972939 | AURECAST BIO 59PF | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-26 | Traditional | PDF ↗ |
| K972938 | AURECAST 10 | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-25 | Traditional | PDF ↗ |
| K972937 | AURECAST 4 | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-25 | Traditional | PDF ↗ |
| K972936 | AURECAST 2 | Aurex Precious Metal Industries (Pty)Ltd | 1997-08-25 | Traditional | PDF ↗ |
| K972632 | VERA PD SOLDER | Aalba Dent, Inc. | 1997-08-15 | Traditional | PDF ↗ |
| K972532 | AALBA GOLD SOLDER | Aalba Dent, Inc. | 1997-08-15 | Traditional | PDF ↗ |
| K971575 | BENCHMARK-IV | J.F. Jelenko & Co., Inc. | 1997-06-04 | Traditional | PDF ↗ |
| K971292 | JEL-71 PDF | J.F. Jelenko & Co., Inc. | 1997-05-20 | Traditional | PDF ↗ |
| K971574 | JELBOND-PDF | J.F. Jelenko & Co., Inc. | 1997-05-20 | Traditional | PDF ↗ |
| K970963 | TARGIS ALLOY #7 | Ivoclar North America, Inc. | 1997-04-30 | Traditional | PDF ↗ |
| K970068 | JELENKO NO.1 (CODE NAME RD-0601) | J.F. Jelenko & Co., Inc. | 1997-03-24 | Traditional | PDF ↗ |
| K964772 | AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS) | Ivoclar North America, Inc. | 1997-01-17 | Traditional | PDF ↗ |
| K964949 | AURORA 53 | Gateway Alloys, Inc. | 1997-01-13 | Traditional | PDF ↗ |
| K964950 | LA PLATA 28 (PM-28) | Gateway Alloys, Inc. | 1997-01-13 | Traditional | PDF ↗ |
| K964941 | EL DORADO 40 | Gateway Alloys, Inc. | 1997-01-13 | Traditional | PDF ↗ |
| K964948 | AURORA 52 (PM-01) | Gateway Alloys, Inc. | 1997-01-13 | Traditional | PDF ↗ |
| K964940 | TAOS 28 | Gateway Alloys, Inc. | 1997-01-13 | Traditional | PDF ↗ |
| K964837 | PACIFIC 56 (CB-40) | Gateway Alloys, Inc. | 1996-12-20 | Traditional | PDF ↗ |
| K964838 | PALLADIA 85 (PM-13) | Gateway Alloys, Inc. | 1996-12-20 | Traditional | PDF ↗ |
| K964792 | LA PLATA 40 | Gateway Alloys, Inc. | 1996-12-20 | Traditional | PDF ↗ |
| K964789 | LA PLATA 39 | Gateway Alloys, Inc. | 1996-12-20 | Traditional | PDF ↗ |
| K964788 | EL DORADO 55 | Gateway Alloys, Inc. | 1996-12-20 | Traditional | PDF ↗ |
| K964708 | SOLDER 615 | Gateway Alloys, Inc. | 1996-12-16 | Traditional | PDF ↗ |
| K964158 | JEL-40 (CODE NAME RD-0430) | Jelenko Co. | 1996-12-13 | Traditional | PDF ↗ |
| K964568 | OZARK 46 | Gateway Alloys, Inc. | 1996-12-06 | Traditional | PDF ↗ |
| K964569 | EL DORADO 58 | Gateway Alloys, Inc. | 1996-12-06 | Traditional | PDF ↗ |
| K964572 | PALLADIA 76 | Gateway Alloys, Inc. | 1996-12-06 | Traditional | PDF ↗ |
| K964567 | EL DORADO 75 | Gateway Alloys, Inc. | 1996-12-06 | Traditional | PDF ↗ |
| K964573 | PIEDMONT 70 (CH-35) | Gateway Alloys, Inc. | 1996-12-06 | Traditional | PDF ↗ |
| K964566 | OZARK 20 | Gateway Alloys, Inc. | 1996-12-06 | Traditional | PDF ↗ |
| K964476 | DE ORO 77 | Gateway Alloys, Inc. | 1996-12-04 | Traditional | PDF ↗ |
| K964477 | OZARK 40 | Gateway Alloys, Inc. | 1996-12-02 | Traditional | PDF ↗ |
| K964478 | OSAGE 76 | Gateway Alloys, Inc. | 1996-11-26 | Traditional | PDF ↗ |
| K964464 | PACIFIC 52 (CB-39) | Gateway Alloys, Inc. | 1996-11-26 | Traditional | PDF ↗ |
| K964465 | LA PLATA 34 (PM-25) | Gateway Alloys, Inc. | 1996-11-26 | Traditional | PDF ↗ |
| K964466 | PALLADIA 75 (PM-11) | Gateway Alloys, Inc. | 1996-11-20 | Traditional | PDF ↗ |
| K962326 | STERNGOLD BIO-5 (1127210) | Sterngold/Implamed | 1996-07-24 | Traditional | PDF ↗ |
| K962325 | QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015) | Sterngold/Implamed | 1996-07-24 | Traditional | PDF ↗ |
| K962303 | STERNGOLD CF | Sterngold/Implamed | 1996-07-18 | Traditional | PDF ↗ |
| K962302 | PEGASUS DENTAL ALLOY | Sterngold/Implamed | 1996-07-18 | Traditional | PDF ↗ |
| K960956 | STERNGOLD M-PF YELLOW CROWN & BRIDGE ALLOY MODEL 1127200 | Sterngold/Implamed | 1996-05-29 | Traditional | PDF ↗ |
| K961352 | 285 SL | Argen Precious Metals, Inc. | 1996-05-20 | Traditional | PDF ↗ |
| K961211 | ARGELITE 52+ | Argen Precious Metals, Inc. | 1996-04-25 | Traditional | PDF ↗ |
| K961285 | ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION) | Argen Precious Metals, Inc. | 1996-04-18 | Traditional | PDF ↗ |
Product code EJT · Class II · Dental. Data: openFDA.