Product code EJT
- Device name
- Alloy, Gold-Based Noble Metal
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.3060
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K052463 | PROMETAL HN86 | Prometal Technologies | 2005-10-14 |
| K041378 | BIO 60 | Kodent, Inc. | 2004-08-02 |
| K040672 | PORTA REFLEX | Wieland Dental + Technik GmbH & Co. KG | 2004-05-27 |
| K040524 | PORTA SOLDER 1090 W | Wieland Dental + Technik GmbH & Co. KG | 2004-05-20 |
| K040043 | NDX-40 ALLOY | Heraeus Kulzer, Inc. | 2004-03-03 |
| 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 |
| K033279 | GOLD DENTAL CASTING ALLOYS | Bego U.S.A. | 2004-01-15 |
| K033446 | APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 | We Dong Myung Dental Industrial Co., Ltd. | 2003-11-13 |
| K033435 | E-SARANG 86, DM78, DM55 | We Dong Myung Dental Industrial Co., Ltd. | 2003-11-12 |
| K032320 | APPOLLO 3 ALLOY | Dentsply International | 2003-10-01 |
| K032321 | CERA F ALLOY | Dentsply International | 2003-09-30 |
| K032319 | CERA R PLUS ALLOY | Dentsply International | 2003-09-30 |
| K032318 | MINERVA 58 ALLOY | Dentsply International | 2003-09-30 |
| K032317 | ORION GX ALLOY | Dentsply Intl. | 2003-09-30 |
| K032316 | ORION E ALLOY | Dentsply Intl. | 2003-09-30 |
| K032715 | DW 296 #15 SOLDER | Ivoclar Vivadent, Inc. | 2003-09-26 |
| K032851 | ULTRACROWN 75 ALLOY | Dentsply International | 2003-09-26 |
| K032267 | R&D DESIGNATION AP-052-5 | Jensen Industries, Inc. | 2003-09-17 |
| K032493 | ALEXANDER | Ivoclar Vivadent, Inc. | 2003-09-04 |
| K032106 | STARBOND DENTAL BONDING ALLOYS | Star Refining Precious Metals South Africa | 2003-08-25 |
| K031010 | MIRACLE 98 | Sb Lucius, Inc. | 2003-06-25 |
| K031264 | PORTA PRESSOVER | Wieland Dental + Technik GmbH & Co. KG | 2003-06-12 |
| K031543 | STARCAST DENTAL ALLOYS | Star Refining Precious Metals South Africa | 2003-05-30 |
| K030436 | BIO UNIVERSAL | Ivoclar Vivadent, Inc. | 2003-04-15 |
| K030435 | BIOUNIVERSAL PKF | Ivoclar Vivadent, Inc. | 2003-04-15 |
| K030312 | PORTA IMPLANT | Wieland Dental + Technik GmbH & Co. KG | 2003-03-26 |
| K024142 | AIGIS-SUPER | Sb Lucius, Inc. | 2003-03-10 |
| K024136 | AIGIS-SOFT | Sb Lucius, Inc. | 2003-03-10 |
| K024143 | AIGIS-FINE | Sb Lucius, Inc. | 2003-03-10 |
| K024135 | AIGIS-PLUS | Sb Lucius, Inc. | 2003-03-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 97640173081787 | Pontor MPF | Cendres+Métaux SA | 2020-11-12 |
| 97640173082326 | S.G 1120 | Cendres+Métaux SA | 2020-11-12 |
| 97640173082319 | S.G 1030 | Cendres+Métaux SA | 2020-11-12 |
| 97640173082302 | S.W 1125 | Cendres+Métaux SA | 2020-11-12 |
| 97640173082289 | S.G 1080 | Cendres+Métaux SA | 2020-11-12 |
| 97640173082272 | S.W 1100 | Cendres+Métaux SA | 2020-11-12 |
| 97640173082265 | S.G 750 | Cendres+Métaux SA | 2020-11-12 |
| 97640173082029 | Aurofluid 2 PF | Cendres+Métaux SA | 2020-11-12 |
| 97640173081930 | Solaro 3 | Cendres+Métaux SA | 2020-11-12 |
| 97640173081565 | Esteticor® Accurate 40 | Cendres+Métaux SA | 2020-11-12 |
| 97640173081138 | Esteticor® Implant 58 | Cendres+Métaux SA | 2020-11-12 |
| 97640173081084 | V-Gnathos Plus | Cendres+Métaux SA | 2020-11-12 |
| 97640173080865 | V-Delta SF | Cendres+Métaux SA | 2020-11-12 |
| 97640173080834 | V-Deltaloy | Cendres+Métaux SA | 2020-11-12 |
| 97640173080803 | V-Delta Special | Cendres+Métaux SA | 2020-11-12 |
| 97640173080643 | Esteticor® Plus | Cendres+Métaux SA | 2020-11-12 |
| D7075840560 | Y Lite | IVOCLAR VIVADENT, INC. | 2017-01-27 |
| D7075840480 | Y 2 | IVOCLAR VIVADENT, INC. | 2017-01-27 |
| D7075840520 | Golden Ceramic | IVOCLAR VIVADENT, INC. | 2017-01-27 |
| D7075840720 | Aquarius XH | IVOCLAR VIVADENT, INC. | 2017-01-27 |
| D7075840610 | Brite Gold | IVOCLAR VIVADENT, INC. | 2017-01-27 |
| D7075840700 | Spartan Plus | IVOCLAR VIVADENT, INC. | 2017-01-27 |
| D7075840710 | Aquarius Hard | IVOCLAR VIVADENT, INC. | 2017-01-27 |
| D7075840470 | W 1 | IVOCLAR VIVADENT, INC. | 2017-01-27 |
| D7075840460 | Y 1 | IVOCLAR VIVADENT, INC. | 2017-01-27 |
| D7075840450 | W 5 | IVOCLAR VIVADENT, INC. | 2017-01-27 |
| D7075840440 | W. | IVOCLAR VIVADENT, INC. | 2017-01-27 |
| D7075840430 | Y. | IVOCLAR VIVADENT, INC. | 2017-01-27 |
| 10852187007368 | Vera PD solder | AALBA DENT INC. | 2017-01-08 |
| 10852187007160 | Aalba Gold Solder | AALBA DENT INC. | 2017-01-08 |