EJS — Alloy, Other Noble Metal Class II
FDA product code EJS covers "Alloy, Other Noble Metal", a Class II medical device regulated under 21 CFR 872.3060. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EJS
- Device Class
- Class II
- Regulation Number
- 872.3060
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K041433 | ivoclar vivadent | BRIGHT GOLD XH | August 19, 2004 |
| K040436 | wieland dental + technik gmbh and co. kg | SIMIDUR SUPERIOR | March 5, 2004 |
| K022252 | sterngold | STERNGOLD 1, MODEL 1127781 | September 19, 2002 |
| K022469 | wieland dental + technik gmbh and co. kg | ECO E4 | September 18, 2002 |
| K021367 | sterngold | STERNGOLD 66, MODEL #1180230 | May 16, 2002 |
| K020192 | wieland dental + technik gmbh and co. kg | SIMIDUR S2 | March 15, 2002 |
| K020195 | wieland dental + technik gmbh and co. kg | SIMIDUR S1S | March 15, 2002 |
| K020194 | wieland dental + technik gmbh and co. kg | SIMIDUR KF PLUS | March 15, 2002 |
| K014042 | ivoclar vivadent | D.SIGN 84 | February 22, 2002 |
| K013809 | ivoclar vivadent | D.SIGN 59 | February 7, 2002 |
| K014082 | ivoclar vivadent | D.SIGN 53, MODEL NA1012204 | January 30, 2002 |
| K012841 | wieland edelmetalle gmbh and | DUO PAL 6, ORDER-NO.: 2154 | November 20, 2001 |
| K012828 | wieland edelmetalle gmbh and | PORTA SMK 82, MODEL 2032 | November 1, 2001 |
| K012840 | wieland edelmetalle gmbh and | EURO 45, ORDER-NO.: 2064 | October 23, 2001 |
| K012303 | j.f. jelenko and co | JEL-20 | August 22, 2001 |
| K003632 | ivoclar north america | DW 273 #1 | December 20, 2000 |
| K001469 | ivoclar north america | R&D PROJECT DW269#25 | July 5, 2000 |
| K000532 | j.f. jelenko and co | JEL 15 | April 6, 2000 |
| K993475 | metalor dental usa | AUROFLUID M, ALLOY NO. 5315 | December 9, 1999 |
| K993505 | metalor dental usa | V-DELTA SPECIAL, ALLOY NO. 5154 | December 8, 1999 |