EJT
627 FDA 510(k) clearances · Product code
41 daysmedian time to decision
97 days90th percentile
627clearances measured
FDA profile
- Official device name
- Alloy, Gold-Based Noble Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3060
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2000: 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 |
|---|---|---|
| PROMETAL HN86 (K052463) | Prometal Technologies | 2005-10-14 |
| BIO 60 (K041378) | Kodent, Inc. | 2004-08-02 |
| PORTA REFLEX (K040672) | Wieland Dental + Technik GmbH & Co. KG | 2004-05-27 |
| PORTA SOLDER 1090 W (K040524) | Wieland Dental + Technik GmbH & Co. KG | 2004-05-20 |
| NDX-40 ALLOY (K040043) | Heraeus Kulzer, Inc. | 2004-03-03 |
| HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM (K034049) | Heraeus Kulzer,GmbH | 2004-03-01 |
| GOLD DENTAL CASTING ALLOYS (K033279) | Bego U.S.A. | 2004-01-15 |
| APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 (K033446) | We Dong Myung Dental Industrial Co., Ltd. | 2003-11-13 |
| E-SARANG 86, DM78, DM55 (K033435) | We Dong Myung Dental Industrial Co., Ltd. | 2003-11-12 |
| APPOLLO 3 ALLOY (K032320) | Dentsply International | 2003-10-01 |
| ORION GX ALLOY (K032317) | Dentsply Intl. | 2003-09-30 |
| CERA R PLUS ALLOY (K032319) | Dentsply International | 2003-09-30 |
| MINERVA 58 ALLOY (K032318) | Dentsply International | 2003-09-30 |
| CERA F ALLOY (K032321) | Dentsply International | 2003-09-30 |
| ORION E ALLOY (K032316) | Dentsply Intl. | 2003-09-30 |
| ULTRACROWN 75 ALLOY (K032851) | Dentsply International | 2003-09-26 |
| DW 296 #15 SOLDER (K032715) | Ivoclar Vivadent, Inc. | 2003-09-26 |
| R&D DESIGNATION AP-052-5 (K032267) | Jensen Industries, Inc. | 2003-09-17 |
| ALEXANDER (K032493) | Ivoclar Vivadent, Inc. | 2003-09-04 |
| STARBOND DENTAL BONDING ALLOYS (K032106) | Star Refining Precious Metals South Africa | 2003-08-25 |
| MIRACLE 98 (K031010) | Sb Lucius, Inc. | 2003-06-25 |
| PORTA PRESSOVER (K031264) | Wieland Dental + Technik GmbH & Co. KG | 2003-06-12 |
| STARCAST DENTAL ALLOYS (K031543) | Star Refining Precious Metals South Africa | 2003-05-30 |
| BIOUNIVERSAL PKF (K030435) | Ivoclar Vivadent, Inc. | 2003-04-15 |
| BIO UNIVERSAL (K030436) | Ivoclar Vivadent, Inc. | 2003-04-15 |
| PORTA IMPLANT (K030312) | Wieland Dental + Technik GmbH & Co. KG | 2003-03-26 |
| AIGIS-SOFT (K024136) | Sb Lucius, Inc. | 2003-03-10 |
| AIGIS-FINE (K024143) | Sb Lucius, Inc. | 2003-03-10 |
| AIGIS-PLUS (K024135) | Sb Lucius, Inc. | 2003-03-10 |
| AIGIS-SUPER (K024142) | Sb Lucius, Inc. | 2003-03-10 |
| AIGIS-XO (K024145) | Sb Lucius, Inc. | 2003-03-07 |
| AIGIS-INLAY (K024139) | Sb Lucius, Inc. | 2003-03-07 |
| AIGIS-PT (K024144) | Sb Lucius, Inc. | 2003-03-07 |
| NEO 76 (K024141) | Sb Lucius, Inc. | 2003-03-06 |
| AIGIS-A (K024140) | Sb Lucius, Inc. | 2003-03-06 |
| APEX 90 (K030206) | We Dong Myung Dental Industrial Co., Ltd. | 2003-01-29 |
| UCP DENTAL MATERIAL (K023831) | Precious Chemicals U.S.A., Inc. | 2003-01-24 |
| UCC DENTAL MATERIAL (K023790) | Precious Chemicals U.S.A., Inc. | 2003-01-21 |
| GOLD CORE 35 (K023501) | Pentron Laboratory Technologies | 2002-12-18 |
| PORTADUR P2 (K023395) | Wieland Dental + Technik GmbH & Co. KG | 2002-12-11 |
| BIOPORTA G (K023391) | Wieland Dental + Technik GmbH & Co. KG | 2002-12-10 |
| AGC SPECIAL ALLOY (K023392) | Wieland Dental + Technik GmbH & Co. KG | 2002-12-06 |
| PORTA GEO TI (K023389) | Wieland Dental + Technik GmbH & Co. KG | 2002-12-06 |
| CERANUM 82 (K023197) | Sb Lucius, Inc. | 2002-11-05 |
| CERANUM 76 (K023200) | Sb Lucius, Inc. | 2002-11-04 |
| CERANUM 50 (K023199) | Sb Lucius, Inc. | 2002-11-04 |
| LUCIUS 76 (K023196) | Sb Lucius, Inc. | 2002-11-01 |
| CERANUM 90 (K023198) | Sb Lucius, Inc. | 2002-11-01 |
| KERADEC (K022663) | Wieland Dental + Technik GmbH & Co. KG | 2002-10-31 |
| UNIVERSAL CERAMIC SOLDER (K022969) | Ivoclar Vivadent, Inc. | 2002-10-18 |
| W-5 (K022811) | Ivoclar Vivadent, Inc. | 2002-10-09 |
| BIOPORTA SOLDER 1020 (K022462) | Wieland Dental + Technik GmbH & Co. KG | 2002-09-18 |
| PORTA SOLDER 1080 W (K022470) | Wieland Dental + Technik GmbH & Co. KG | 2002-09-18 |
| PORTA OPTIMUM SOLDER 900 (K022468) | Wieland Dental + Technik GmbH & Co. KG | 2002-09-17 |
| PORTA IP SOLDER V-1 (K022456) | Wieland Dental + Technik GmbH & Co. KG | 2002-09-17 |
| PORTA IP SOLDER V-2 (K022467) | Wieland Dental + Technik GmbH & Co. KG | 2002-09-17 |
| PORTA OPTIMUM SOLDER 710 (K022457) | Wieland Dental + Technik GmbH & Co. KG | 2002-09-17 |
| PORTA OP SOLDER W-2 (K022454) | Wieland Dental + Technik GmbH & Co. KG | 2002-09-12 |
| AUROPAL SOLDER M-1 (K022459) | Wieland Dental + Technik GmbH & Co. KG | 2002-09-12 |
| AUROPAL SOLDER W-2 (K022451) | Wieland Dental + Technik GmbH & Co. KG | 2002-09-11 |
| PORTA OP SOLDER M-1 (K022452) | Wieland Dental + Technik GmbH & Co. KG | 2002-09-11 |
| LUCIUS 62 (K021948) | Lucius Metals Com. | 2002-09-03 |
| JENSEN GOLD FOIL (K022206) | Jensen Industries, Inc. | 2002-08-29 |
| CERANUM 87 (K021947) | Lucius Metals Com. | 2002-08-26 |
| AUROPAL 60 (K021926) | Wieland Dental + Technik GmbH & Co. KG | 2002-07-25 |
| BRIGHT GOLD (K021892) | Ivoclar Vivadent, Inc. | 2002-07-25 |
| AUTOPAL 50 (K021733) | Wieland Dental + Technik GmbH & Co. KG | 2002-06-26 |
| CRITERTION, MODEL #1067511 (K021741) | Sterngold | 2002-06-26 |
| PORTALLOY 54 (K021242) | Wieland Dental + Technik GmbH & Co. KG | 2002-05-16 |
| AGC SPEZIALLEGIERUNG (K020347) | Wieland Edelmetalle GmbH & Co. | 2002-04-24 |
| APOLLO, MODEL 1124525 (K020949) | Sterngold | 2002-04-04 |
| PORTADUR P 4 (K020190) | Wieland Dental + Technik GmbH & Co. KG | 2002-03-13 |
| V-GNATHOS SUPRA (K013769) | Metalor Technologies USA | 2002-01-22 |
| YELLOW SPECIAL (K013506) | Metalor Technologies USA | 2002-01-03 |
| AUROPAL, ORDER-NO.: 2101 (K012839) | Wieland Edelmetalle GmbH & Co. | 2001-12-31 |
| AUROFLUID PLUS (K013505) | Metalor Technologies USA | 2001-12-19 |
| HIGH GOLD PALLADIUM FREE CERAMIC SOLDER (K012877) | Ivoclar USA, Inc. | 2001-11-21 |
| PORTADUR P 2, MODEL #2031 (K012843) | Wieland Edelmetalle GmbH & Co. | 2001-11-02 |
| PORTA AURIUM, MODEL 2067 (K012827) | Wieland Edelmetalle GmbH & Co. | 2001-11-01 |
| PORTA GEO TI MODEL #2004 (K012834) | Wieland Edelmetalle GmbH & Co. | 2001-11-01 |
| BIO PORTADUR, ORDER-NO.:2017 (K012831) | Wieland Edelmetalle GmbH & Co. | 2001-11-01 |
| PORTA MAXIMUM, MODEL# 2066 (K012835) | Wieland Edelmetalle GmbH & Co. | 2001-11-01 |
| BIOPORTA G, MODEL 2052 (K012826) | Wieland Edelmetalle GmbH & Co. | 2001-11-01 |
| ERO50, ORDER-NO.: 2070 (K012838) | Wieland Edelmetalle GmbH & Co. | 2001-10-23 |
| GPW-SF (K011659) | Gateway Alloys, Inc. | 2001-08-27 |
| CONCORD 88 (K011661) | Gateway Alloys, Inc. | 2001-08-27 |
| CONCORD 82 (K011628) | Gateway Alloys, Inc. | 2001-07-16 |
| CONCORD 72 (K011626) | Gateway Alloys, Inc. | 2001-07-16 |
| JP CAST 50 (K011330) | Jeneric/Pentron, Inc. | 2001-06-22 |
| JP CAST 40 (K011331) | Jeneric/Pentron, Inc. | 2001-06-22 |
| GOLD CORE 73 LS (K011362) | Jeneric/Pentron, Inc. | 2001-05-29 |
| RD-3008 (K011036) | Heraeus Kulzer, Inc. | 2001-05-10 |
| BIOUNIVERSAL PDF (K011022) | Ivoclar North America, Inc. | 2001-05-02 |
| D.SIGN 96 (K011023) | Ivoclar North America, Inc. | 2001-05-02 |
| R & D DESIGNATION AP-035 (K010414) | Jensen Industries, Inc. | 2001-03-27 |
| R & D DESIGNATION AP-047 (K010611) | Jensen Industries, Inc. | 2001-03-27 |
| HERACERAM 75 (K010416) | Jelenko Co. | 2001-03-08 |
| COSMIC (K010044) | Jeneric/Pentron, Inc. | 2001-02-09 |
| BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE (K003603) | Jelenko Co. | 2001-01-10 |
| DW 276 #3 (K003635) | Ivoclar North America, Inc. | 2000-12-22 |
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