FDA product code EJJ: Alloy, Amalgam
EJJ is the FDA product code for alloy, amalgam. It is a Class II device, regulated under 21 CFR 872.3070 and reviewed by the Dental panel. FDA has cleared 74 510(k) submissions under EJJ, from 42 different applicants. The average 510(k) review took 63 days (median 52). FDA has posted 2 recalls for EJJ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Alloy, Amalgam |
| Device class | Class II |
| Regulation | 21 CFR 872.3070 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every EJJ clearance
Top EJJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Southern Dental Industries, Inc. | 6 | 2003-08-06 |
| Ab Ardent | 5 | 2002-05-07 |
| Goldsmith & Revere, Inc. | 4 | 1995-05-25 |
| Ivoclar North America, Inc. | 4 | 1991-03-29 |
| Nordiska Dental AB | 3 | 2000-10-31 |
37 more applicants have EJJ clearances. See the full list in Caduvo.
Most recent EJJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K053114 | Dunia Perwira Manufacturing Sdn. Bhd. | SILVERFIL | 2005-11-15 | 8 |
| K051010 | Septodont | SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 | 2005-05-02 | 11 |
| K033434 | We Dong Myung Dental Industrial Co., Ltd. | BESTALOY | 2003-11-12 | 15 |
| K032152 | Southern Dental Industries, Inc. | BENCO ADMIX | 2003-08-06 | 70 |
| K031658 | Southern Dental Industries, Inc. | BENCO SPHERICAL | 2003-07-29 | 62 |
Recalls for EJJ devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-12-21.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code EJJ?
EJJ is the FDA product code for alloy, amalgam. It is a Class II device, regulated under 21 CFR 872.3070 and reviewed by the Dental panel.
What device class is EJJ?
Class II, regulation 21 CFR 872.3070. Typical premarket route: 510(k).
How long does a 510(k) take for product code EJJ?
Across 74 cleared submissions the average was 63 days from receipt to decision (median 52).
Which companies have the most EJJ clearances?
Southern Dental Industries, Inc. (6); Ab Ardent (5); Goldsmith & Revere, Inc. (4); Ivoclar North America, Inc. (4); Nordiska Dental AB (3).
Have EJJ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2023-12-21.
Next steps
- Run an FDA pathway report with predicate devices for product code EJJ
- Run a recall and safety report across every EJJ manufacturer
- Watch product code EJJ 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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