FDA product code EJT: Alloy, Gold-Based Noble Metal
EJT is the FDA product code for alloy, gold-based noble metal. It is a Class II device, regulated under 21 CFR 872.3060 and reviewed by the Dental panel. FDA has cleared 627 510(k) submissions under EJT, from 64 different applicants. The average 510(k) review took 57 days (median 41).
Classification
| Field | Value |
|---|---|
| Device name | Alloy, Gold-Based 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 EJT clearance
Top EJT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Argen Precious Metals, Inc. | 201 | 1996-05-20 |
| J.F. Jelenko & Co., Inc. | 38 | 2000-10-19 |
| Metalor Dental USA Corp. | 31 | 1999-12-06 |
| Ivoclar North America, Inc. | 29 | 2001-05-02 |
| Gateway Alloys, Inc. | 27 | 2001-08-27 |
59 more applicants have EJT clearances. See the full list in Caduvo.
Most recent EJT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K052463 | Prometal Technologies | PROMETAL HN86 | 2005-10-14 | 36 |
| K041378 | Kodent, Inc. | BIO 60 | 2004-08-02 | 70 |
| K040672 | Wieland Dental + Technik GmbH & Co. KG | PORTA REFLEX | 2004-05-27 | 73 |
| K040524 | Wieland Dental + Technik GmbH & Co. KG | PORTA SOLDER 1090 W | 2004-05-20 | 80 |
| K040043 | Heraeus Kulzer, Inc. | NDX-40 ALLOY | 2004-03-03 | 51 |
Recalls for EJT devices
openFDA lists no recalls for product code EJT.
Frequently asked questions
What is FDA product code EJT?
EJT is the FDA product code for alloy, gold-based noble metal. It is a Class II device, regulated under 21 CFR 872.3060 and reviewed by the Dental panel.
What device class is EJT?
Class II, regulation 21 CFR 872.3060. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EJT?
Across 627 cleared submissions the average was 57 days from receipt to decision (median 41).
Which companies have the most EJT 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).
Next steps
- Run an FDA pathway report with predicate devices for product code EJT
- Run a recall and safety report across every EJT manufacturer
- Watch product code EJT 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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