FDA product code · Dental
EJTAlloy, Gold-Based Noble Metal
Product code EJT covers Alloy, Gold-Based Noble Metal, a Class II device regulated under 21 CFR 872.3060. FDA has cleared 627 devices in this code. Median review time across the 627 most recent decisions is 41 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
- 627
What is happening in EJT right now?
EJT (Alloy, Gold-Based 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 EJT?
FDA has cleared 627 devices under product code EJT since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052463 | PROMETAL HN86 | Prometal Technologies | |
| K041378 | BIO 60 | Kodent, Inc. | |
| K040672 | PORTA REFLEX | Wieland Dental + Technik GmbH & Co. KG | |
| K040524 | PORTA SOLDER 1090 W | Wieland Dental + Technik GmbH & Co. KG | |
| K040043 | NDX-40 ALLOY | Heraeus Kulzer, Inc. | |
| 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 | |
| K033279 | GOLD DENTAL CASTING ALLOYS | Bego U.S.A. | |
| K033446 | APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 | We Dong Myung Dental Industrial Co., Ltd. | |
| K033435 | E-SARANG 86, DM78, DM55 | We Dong Myung Dental Industrial Co., Ltd. | |
| K032320 | APPOLLO 3 ALLOY | Dentsply International |
How long does FDA review take for EJT?
The median FDA review time for EJT is 41 days, measured across the 627 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 EJT?
openFDA lists no recall records against product code EJT. That is the absence of a record, not a guarantee of safety.
Source: openFDA device/recall · retrieved
How many adverse events are reported for EJT?
MAUDE holds no adverse-event reports naming product code EJT.
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 EJT?
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 EJT?
Across the 627 most recent decisions, these applicants filed most often in EJT.
| Applicant | Recent clearances |
|---|---|
| Argen Precious Metals, Inc. | 201 |
| J.F. Jelenko & Co., Inc. | 38 |
| Metalor Dental USA Corp. | 31 |
| Ivoclar North America, Inc. | 29 |
| Gateway Alloys, Inc. | 27 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch EJT
Get an email the morning anything changes in EJT — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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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.