Product code EJS
- Device name
- Alloy, Other 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 |
|---|---|---|---|
| K041433 | BRIGHT GOLD XH | Ivoclar Vivadent, Inc. | 2004-08-19 |
| K040436 | SIMIDUR SUPERIOR | Wieland Dental + Technik GmbH & Co. KG | 2004-03-05 |
| K022252 | STERNGOLD 1, MODEL 1127781 | Sterngold | 2002-09-19 |
| K022469 | ECO E4 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-18 |
| K021367 | STERNGOLD 66, MODEL #1180230 | Sterngold | 2002-05-16 |
| K020192 | SIMIDUR S2 | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 |
| K020194 | SIMIDUR KF PLUS | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 |
| K020195 | SIMIDUR S1S | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 |
| K014042 | D.SIGN 84 | Ivoclar Vivadent, Inc. | 2002-02-22 |
| K013809 | D.SIGN 59 | Ivoclar Vivadent, Inc. | 2002-02-07 |
| K014082 | D.SIGN 53, MODEL NA1012204 | Ivoclar Vivadent, Inc. | 2002-01-30 |
| K012841 | DUO PAL 6, ORDER-NO.: 2154 | Wieland Edelmetalle GmbH & Co. | 2001-11-20 |
| K012828 | PORTA SMK 82, MODEL 2032 | Wieland Edelmetalle GmbH & Co. | 2001-11-01 |
| K012840 | EURO 45, ORDER-NO.: 2064 | Wieland Edelmetalle GmbH & Co. | 2001-10-23 |
| K012303 | JEL-20 | J.F. Jelenko & Co., Inc. | 2001-08-22 |
| K003632 | DW 273 #1 | Ivoclar North America, Inc. | 2000-12-20 |
| K001469 | R&D PROJECT DW269#25 | Ivoclar North America, Inc. | 2000-07-05 |
| K000532 | JEL 15 | J.F. Jelenko & Co., Inc. | 2000-04-06 |
| K993475 | AUROFLUID M, ALLOY NO. 5315 | Metalor Dental USA Corp. | 1999-12-09 |
| K993506 | PAGALINOR 4 , ALLOY NO. 5440 | Metalor Dental USA Corp. | 1999-12-08 |
| K993505 | V-DELTA SPECIAL, ALLOY NO. 5154 | Metalor Dental USA Corp. | 1999-12-08 |
| K993474 | DELTAPAL, ALLOY NO. 5161 | Metalor Dental USA Corp. | 1999-12-02 |
| K984587 | ALLROUND-E (CODE NAME RD 1710) | J.F. Jelenko & Co., Inc. | 1999-03-17 |
| K990077 | D-SIGN III (R&D PROJECT DW264#7) | Ivoclar North America, Inc. | 1999-02-12 |
| K990078 | D-SIGN IV (R&D PROJECT DW265#37) | Ivoclar North America, Inc. | 1999-02-12 |
| K984451 | D-SIGN I (R&D PROJECT DW263 #24) | Ivoclar North America, Inc. | 1999-01-19 |
| K983081 | BEGOPAL 300 | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | 1998-10-28 |
| K983078 | BEGOPAL | Bego U.S.A. | 1998-10-23 |
| K981257 | JELFINE-52 (CODE NAME RD-0901) | J.F. Jelenko & Co., Inc. | 1998-08-13 |
| K981247 | SILCAST (CODE NAME RD-0118) | J.F. Jelenko & Co., Inc. | 1998-07-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 14260576943467 | CEKA & PRECI-LINE ATTACHMENTS | Alphadent NV | 2021-03-30 |
| 14260576941777 | CEKA & PRECI-LINE ATTACHMENTS | Alphadent NV | 2021-03-30 |
| 14260576941760 | CEKA & PRECI-LINE ATTACHMENTS | Alphadent NV | 2021-03-30 |
| 14260576941753 | CEKA & PRECI-LINE ATTACHMENTS | Alphadent NV | 2021-03-30 |
| 14260576941746 | CEKA & PRECI-LINE ATTACHMENTS | Alphadent NV | 2021-03-30 |
| 14260576941739 | CEKA & PRECI-LINE ATTACHMENTS | Alphadent NV | 2021-03-30 |
| 97640173081268 | Ceradelta | Cendres+Métaux SA | 2020-11-12 |
| 97640173080971 | Cerapall 2 | Cendres+Métaux SA | 2020-11-12 |
| 97640173080711 | Cerapall 6 | Cendres+Métaux SA | 2020-11-12 |
| 97640173080537 | Ceradelta 2 | Cendres+Métaux SA | 2020-11-12 |
| D7075733730 | Universal Solder PKF | IVOCLAR VIVADENT, INC. | 2018-10-29 |
| D7075840490 | W 3 | IVOCLAR VIVADENT, INC. | 2017-01-27 |
| 10852187007405 | Vera solder | AALBA DENT INC. | 2017-01-08 |
| 08033707002062 | LEONE SPA | LEONE SPA | 2016-09-25 |
| 08033707069706 | LEONE SPA | LEONE SPA | 2016-09-25 |
| 08033707069690 | LEONE SPA | LEONE SPA | 2016-09-25 |
| 08033707069683 | LEONE SPA | LEONE SPA | 2016-09-25 |
| 08033707069676 | LEONE SPA | LEONE SPA | 2016-09-25 |
| 08033707069669 | LEONE SPA | LEONE SPA | 2016-09-25 |
| 08033707002123 | LEONE SPA | LEONE SPA | 2016-09-25 |
| 08033707002116 | LEONE SPA | LEONE SPA | 2016-09-25 |
| 08033707002109 | LEONE SPA | LEONE SPA | 2016-09-25 |
| 08033707002093 | LEONE SPA | LEONE SPA | 2016-09-25 |
| 08033707002086 | LEONE SPA | LEONE SPA | 2016-09-25 |
| 08033707002079 | LEONE SPA | LEONE SPA | 2016-09-25 |
| 08033707002055 | LEONE SPA | LEONE SPA | 2016-09-25 |
| J011380604500 | N.A. | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011380604600 | N.A. | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011380704500 | N.A. | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011380600500 | N.A. | DENTAURUM GmbH & Co.KG | 2016-09-15 |