FDA product code EJS: Alloy, Other Noble Metal
EJS is the FDA product code for alloy, other noble metal. It is a Class II device, regulated under 21 CFR 872.3060 and reviewed by the Dental panel. FDA has cleared 194 510(k) submissions under EJS, from 45 different applicants. The average 510(k) review took 59 days (median 52).
Classification
| Field | Value |
|---|---|
| Device name | Alloy, Other Noble Metal |
| Device class | Class II |
| Regulation | 21 CFR 872.3060 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EJS clearance
Top EJS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Metalor Dental USA Corp. | 31 | 1999-12-09 |
| Deringer-Ney, Inc. | 14 | 1992-12-21 |
| Ivoclar North America, Inc. | 12 | 2000-12-20 |
| J.F. Jelenko & Co., Inc. | 11 | 2001-08-22 |
| Jeneric/Pentron, Inc. | 10 | 1994-02-04 |
40 more applicants have EJS clearances. See the full list in Caduvo.
Most recent EJS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K041433 | Ivoclar Vivadent, Inc. | BRIGHT GOLD XH | 2004-08-19 | 83 |
| K040436 | Wieland Dental + Technik GmbH & Co. KG | SIMIDUR SUPERIOR | 2004-03-05 | 15 |
| K022252 | Sterngold | STERNGOLD 1, MODEL 1127781 | 2002-09-19 | 69 |
| K022469 | Wieland Dental + Technik GmbH & Co. KG | ECO E4 | 2002-09-18 | 54 |
| K021367 | Sterngold | STERNGOLD 66, MODEL #1180230 | 2002-05-16 | 16 |
Recalls for EJS devices
openFDA lists no recalls for product code EJS.
Frequently asked questions
What is FDA product code EJS?
EJS is the FDA product code for alloy, other noble metal. It is a Class II device, regulated under 21 CFR 872.3060 and reviewed by the Dental panel.
What device class is EJS?
Class II, regulation 21 CFR 872.3060. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EJS?
Across 194 cleared submissions the average was 59 days from receipt to decision (median 52).
Which companies have the most EJS clearances?
Metalor Dental USA Corp. (31); Deringer-Ney, Inc. (14); Ivoclar North America, Inc. (12); J.F. Jelenko & Co., Inc. (11); Jeneric/Pentron, Inc. (10).
Next steps
- Run an FDA pathway report with predicate devices for product code EJS
- Run a recall and safety report across every EJS manufacturer
- Watch product code EJS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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