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 1 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K052463 | PROMETAL HN86 | Prometal Technologies | 2005-10-14 | Traditional | PDF ↗ |
| K041378 | BIO 60 | Kodent, Inc. | 2004-08-02 | Traditional | PDF ↗ |
| K040672 | PORTA REFLEX | Wieland Dental + Technik GmbH & Co. KG | 2004-05-27 | Traditional | PDF ↗ |
| K040524 | PORTA SOLDER 1090 W | Wieland Dental + Technik GmbH & Co. KG | 2004-05-20 | Traditional | PDF ↗ |
| K040043 | NDX-40 ALLOY | Heraeus Kulzer, Inc. | 2004-03-03 | Traditional | PDF ↗ |
| K034049 | HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM | Heraeus Kulzer,GmbH | 2004-03-01 | Traditional | PDF ↗ |
| K033279 | GOLD DENTAL CASTING ALLOYS | Bego U.S.A. | 2004-01-15 | Traditional | PDF ↗ |
| K033446 | APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 | We Dong Myung Dental Industrial Co., Ltd. | 2003-11-13 | Traditional | PDF ↗ |
| K033435 | E-SARANG 86, DM78, DM55 | We Dong Myung Dental Industrial Co., Ltd. | 2003-11-12 | Traditional | PDF ↗ |
| K032320 | APPOLLO 3 ALLOY | Dentsply International | 2003-10-01 | Traditional | PDF ↗ |
| K032321 | CERA F ALLOY | Dentsply International | 2003-09-30 | Traditional | PDF ↗ |
| K032319 | CERA R PLUS ALLOY | Dentsply International | 2003-09-30 | Traditional | PDF ↗ |
| K032316 | ORION E ALLOY | Dentsply Intl. | 2003-09-30 | Traditional | PDF ↗ |
| K032318 | MINERVA 58 ALLOY | Dentsply International | 2003-09-30 | Traditional | PDF ↗ |
| K032317 | ORION GX ALLOY | Dentsply Intl. | 2003-09-30 | Traditional | PDF ↗ |
| K032715 | DW 296 #15 SOLDER | Ivoclar Vivadent, Inc. | 2003-09-26 | Traditional | PDF ↗ |
| K032851 | ULTRACROWN 75 ALLOY | Dentsply International | 2003-09-26 | Special | PDF ↗ |
| K032267 | R&D DESIGNATION AP-052-5 | Jensen Industries, Inc. | 2003-09-17 | Traditional | PDF ↗ |
| K032493 | ALEXANDER | Ivoclar Vivadent, Inc. | 2003-09-04 | Traditional | PDF ↗ |
| K032106 | STARBOND DENTAL BONDING ALLOYS | Star Refining Precious Metals South Africa | 2003-08-25 | Traditional | PDF ↗ |
| K031010 | MIRACLE 98 | Sb Lucius, Inc. | 2003-06-25 | Traditional | PDF ↗ |
| K031264 | PORTA PRESSOVER | Wieland Dental + Technik GmbH & Co. KG | 2003-06-12 | Traditional | PDF ↗ |
| K031543 | STARCAST DENTAL ALLOYS | Star Refining Precious Metals South Africa | 2003-05-30 | Traditional | PDF ↗ |
| K030435 | BIOUNIVERSAL PKF | Ivoclar Vivadent, Inc. | 2003-04-15 | Traditional | PDF ↗ |
| K030436 | BIO UNIVERSAL | Ivoclar Vivadent, Inc. | 2003-04-15 | Traditional | PDF ↗ |
| K030312 | PORTA IMPLANT | Wieland Dental + Technik GmbH & Co. KG | 2003-03-26 | Traditional | PDF ↗ |
| K024143 | AIGIS-FINE | Sb Lucius, Inc. | 2003-03-10 | Traditional | PDF ↗ |
| K024135 | AIGIS-PLUS | Sb Lucius, Inc. | 2003-03-10 | Traditional | PDF ↗ |
| K024142 | AIGIS-SUPER | Sb Lucius, Inc. | 2003-03-10 | Traditional | PDF ↗ |
| K024136 | AIGIS-SOFT | Sb Lucius, Inc. | 2003-03-10 | Traditional | PDF ↗ |
| K024145 | AIGIS-XO | Sb Lucius, Inc. | 2003-03-07 | Traditional | PDF ↗ |
| K024144 | AIGIS-PT | Sb Lucius, Inc. | 2003-03-07 | Traditional | PDF ↗ |
| K024139 | AIGIS-INLAY | Sb Lucius, Inc. | 2003-03-07 | Traditional | PDF ↗ |
| K024141 | NEO 76 | Sb Lucius, Inc. | 2003-03-06 | Traditional | PDF ↗ |
| K024140 | AIGIS-A | Sb Lucius, Inc. | 2003-03-06 | Traditional | PDF ↗ |
| K030206 | APEX 90 | We Dong Myung Dental Industrial Co., Ltd. | 2003-01-29 | Traditional | PDF ↗ |
| K023831 | UCP DENTAL MATERIAL | Precious Chemicals U.S.A., Inc. | 2003-01-24 | Traditional | PDF ↗ |
| K023790 | UCC DENTAL MATERIAL | Precious Chemicals U.S.A., Inc. | 2003-01-21 | Traditional | PDF ↗ |
| K023501 | GOLD CORE 35 | Pentron Laboratory Technologies | 2002-12-18 | Traditional | PDF ↗ |
| K023395 | PORTADUR P2 | Wieland Dental + Technik GmbH & Co. KG | 2002-12-11 | Traditional | PDF ↗ |
| K023391 | BIOPORTA G | Wieland Dental + Technik GmbH & Co. KG | 2002-12-10 | Traditional | PDF ↗ |
| K023392 | AGC SPECIAL ALLOY | Wieland Dental + Technik GmbH & Co. KG | 2002-12-06 | Traditional | PDF ↗ |
| K023389 | PORTA GEO TI | Wieland Dental + Technik GmbH & Co. KG | 2002-12-06 | Traditional | PDF ↗ |
| K023197 | CERANUM 82 | Sb Lucius, Inc. | 2002-11-05 | Traditional | PDF ↗ |
| K023199 | CERANUM 50 | Sb Lucius, Inc. | 2002-11-04 | Traditional | PDF ↗ |
| K023200 | CERANUM 76 | Sb Lucius, Inc. | 2002-11-04 | Traditional | PDF ↗ |
| K023196 | LUCIUS 76 | Sb Lucius, Inc. | 2002-11-01 | Traditional | PDF ↗ |
| K023198 | CERANUM 90 | Sb Lucius, Inc. | 2002-11-01 | Traditional | PDF ↗ |
| K022663 | KERADEC | Wieland Dental + Technik GmbH & Co. KG | 2002-10-31 | Traditional | PDF ↗ |
| K022969 | UNIVERSAL CERAMIC SOLDER | Ivoclar Vivadent, Inc. | 2002-10-18 | Traditional | PDF ↗ |
| K022811 | W-5 | Ivoclar Vivadent, Inc. | 2002-10-09 | Traditional | PDF ↗ |
| K022470 | PORTA SOLDER 1080 W | Wieland Dental + Technik GmbH & Co. KG | 2002-09-18 | Traditional | PDF ↗ |
| K022462 | BIOPORTA SOLDER 1020 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-18 | Traditional | PDF ↗ |
| K022468 | PORTA OPTIMUM SOLDER 900 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-17 | Traditional | PDF ↗ |
| K022457 | PORTA OPTIMUM SOLDER 710 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-17 | Traditional | PDF ↗ |
| K022456 | PORTA IP SOLDER V-1 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-17 | Traditional | PDF ↗ |
| K022467 | PORTA IP SOLDER V-2 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-17 | Traditional | PDF ↗ |
| K022459 | AUROPAL SOLDER M-1 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-12 | Traditional | PDF ↗ |
| K022454 | PORTA OP SOLDER W-2 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-12 | Traditional | PDF ↗ |
| K022452 | PORTA OP SOLDER M-1 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-11 | Traditional | PDF ↗ |
| K022451 | AUROPAL SOLDER W-2 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-11 | Traditional | PDF ↗ |
| K021948 | LUCIUS 62 | Lucius Metals Com. | 2002-09-03 | Traditional | PDF ↗ |
| K022206 | JENSEN GOLD FOIL | Jensen Industries, Inc. | 2002-08-29 | Traditional | PDF ↗ |
| K021947 | CERANUM 87 | Lucius Metals Com. | 2002-08-26 | Traditional | PDF ↗ |
| K021926 | AUROPAL 60 | Wieland Dental + Technik GmbH & Co. KG | 2002-07-25 | Traditional | PDF ↗ |
| K021892 | BRIGHT GOLD | Ivoclar Vivadent, Inc. | 2002-07-25 | Traditional | PDF ↗ |
| K021733 | AUTOPAL 50 | Wieland Dental + Technik GmbH & Co. KG | 2002-06-26 | Traditional | PDF ↗ |
| K021741 | CRITERTION, MODEL #1067511 | Sterngold | 2002-06-26 | Abbreviated | PDF ↗ |
| K021242 | PORTALLOY 54 | Wieland Dental + Technik GmbH & Co. KG | 2002-05-16 | Traditional | PDF ↗ |
| K020347 | AGC SPEZIALLEGIERUNG | Wieland Edelmetalle GmbH & Co. | 2002-04-24 | Traditional | PDF ↗ |
| K020949 | APOLLO, MODEL 1124525 | Sterngold | 2002-04-04 | Abbreviated | PDF ↗ |
| K020190 | PORTADUR P 4 | Wieland Dental + Technik GmbH & Co. KG | 2002-03-13 | Traditional | PDF ↗ |
| K013769 | V-GNATHOS SUPRA | Metalor Technologies USA | 2002-01-22 | Traditional | PDF ↗ |
| K013506 | YELLOW SPECIAL | Metalor Technologies USA | 2002-01-03 | Traditional | PDF ↗ |
| K012839 | AUROPAL, ORDER-NO.: 2101 | Wieland Edelmetalle GmbH & Co. | 2001-12-31 | Traditional | PDF ↗ |
| K013505 | AUROFLUID PLUS | Metalor Technologies USA | 2001-12-19 | Traditional | PDF ↗ |
| K012877 | HIGH GOLD PALLADIUM FREE CERAMIC SOLDER | Ivoclar USA, Inc. | 2001-11-21 | Traditional | PDF ↗ |
| K012843 | PORTADUR P 2, MODEL #2031 | Wieland Edelmetalle GmbH & Co. | 2001-11-02 | Traditional | PDF ↗ |
| K012834 | PORTA GEO TI MODEL #2004 | Wieland Edelmetalle GmbH & Co. | 2001-11-01 | Traditional | PDF ↗ |
| K012826 | BIOPORTA G, MODEL 2052 | Wieland Edelmetalle GmbH & Co. | 2001-11-01 | Traditional | PDF ↗ |
| K012835 | PORTA MAXIMUM, MODEL# 2066 | Wieland Edelmetalle GmbH & Co. | 2001-11-01 | Traditional | PDF ↗ |
| K012827 | PORTA AURIUM, MODEL 2067 | Wieland Edelmetalle GmbH & Co. | 2001-11-01 | Traditional | PDF ↗ |
| K012831 | BIO PORTADUR, ORDER-NO.:2017 | Wieland Edelmetalle GmbH & Co. | 2001-11-01 | Traditional | PDF ↗ |
| K012838 | ERO50, ORDER-NO.: 2070 | Wieland Edelmetalle GmbH & Co. | 2001-10-23 | Traditional | PDF ↗ |
| K011661 | CONCORD 88 | Gateway Alloys, Inc. | 2001-08-27 | Abbreviated | PDF ↗ |
| K011659 | GPW-SF | Gateway Alloys, Inc. | 2001-08-27 | Traditional | PDF ↗ |
| K011628 | CONCORD 82 | Gateway Alloys, Inc. | 2001-07-16 | Abbreviated | PDF ↗ |
| K011626 | CONCORD 72 | Gateway Alloys, Inc. | 2001-07-16 | Abbreviated | PDF ↗ |
| K011330 | JP CAST 50 | Jeneric/Pentron, Inc. | 2001-06-22 | Traditional | PDF ↗ |
| K011331 | JP CAST 40 | Jeneric/Pentron, Inc. | 2001-06-22 | Traditional | PDF ↗ |
| K011362 | GOLD CORE 73 LS | Jeneric/Pentron, Inc. | 2001-05-29 | Traditional | PDF ↗ |
| K011036 | RD-3008 | Heraeus Kulzer, Inc. | 2001-05-10 | Traditional | PDF ↗ |
| K011022 | BIOUNIVERSAL PDF | Ivoclar North America, Inc. | 2001-05-02 | Traditional | PDF ↗ |
| K011023 | D.SIGN 96 | Ivoclar North America, Inc. | 2001-05-02 | Traditional | PDF ↗ |
| K010611 | R & D DESIGNATION AP-047 | Jensen Industries, Inc. | 2001-03-27 | Abbreviated | PDF ↗ |
| K010414 | R & D DESIGNATION AP-035 | Jensen Industries, Inc. | 2001-03-27 | Abbreviated | PDF ↗ |
| K010416 | HERACERAM 75 | Jelenko Co. | 2001-03-08 | Traditional | PDF ↗ |
| K010044 | COSMIC | Jeneric/Pentron, Inc. | 2001-02-09 | Traditional | PDF ↗ |
| K003603 | BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE | Jelenko Co. | 2001-01-10 | Traditional | PDF ↗ |
| K003635 | DW 276 #3 | Ivoclar North America, Inc. | 2000-12-22 | Traditional | PDF ↗ |
Product code EJT · Class II · Dental. Data: openFDA.