FDA product code · Dental
EJSAlloy, Other Noble Metal
Product code EJS covers Alloy, Other Noble Metal, a Class II device regulated under 21 CFR 872.3060. FDA has cleared 194 devices in this code. Median review time across the 194 most recent decisions is 52 days. openFDA lists no recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 872.3060
- Review panel
- Dental
- Clearances
- 194
What is happening in EJS right now?
EJS (Alloy, Other Noble Metal): nothing changed in the six FDA sources we watch.
Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.
How many devices has FDA cleared in EJS?
FDA has cleared 194 devices under product code EJS since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K041433 | BRIGHT GOLD XH | Ivoclar Vivadent, Inc. | |
| K040436 | SIMIDUR SUPERIOR | Wieland Dental + Technik GmbH & Co. KG | |
| K022252 | STERNGOLD 1, MODEL 1127781 | Sterngold | |
| K022469 | ECO E4 | Wieland Dental + Technik GmbH & Co. KG | |
| K021367 | STERNGOLD 66, MODEL #1180230 | Sterngold | |
| K020195 | SIMIDUR S1S | Wieland Dental + Technik GmbH & Co. KG | |
| K020194 | SIMIDUR KF PLUS | Wieland Dental + Technik GmbH & Co. KG | |
| K020192 | SIMIDUR S2 | Wieland Dental + Technik GmbH & Co. KG | |
| K014042 | D.SIGN 84 | Ivoclar Vivadent, Inc. | |
| K013809 | D.SIGN 59 | Ivoclar Vivadent, Inc. |
How long does FDA review take for EJS?
The median FDA review time for EJS is 52 days, measured across the 194 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in EJS?
openFDA lists no recall records against product code EJS. That is the absence of a record, not a guarantee of safety.
Source: openFDA device/recall · retrieved
How many adverse events are reported for EJS?
MAUDE holds no adverse-event reports naming product code EJS.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
What are the predicate devices in EJS?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in EJS?
Across the 194 most recent decisions, these applicants filed most often in EJS.
| Applicant | Recent clearances |
|---|---|
| Metalor Dental USA Corp. | 31 |
| Deringer-Ney, Inc. | 14 |
| Ivoclar North America, Inc. | 12 |
| J.F. Jelenko & Co., Inc. | 11 |
| Degussa Dental, Inc. | 10 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch EJS
Get an email the morning anything changes in EJS — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Dental
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.