FDA product code EJH: Alloy, Metal, Base
EJH is the FDA product code for alloy, metal, base. It is a Class II device, regulated under 21 CFR 872.3710 and reviewed by the Dental panel. FDA has cleared 153 510(k) submissions under EJH, from 63 different applicants. The average 510(k) review took 74 days (median 54).
Classification
| Field | Value |
|---|---|
| Device name | Alloy, Metal, Base |
| Device class | Class II |
| Regulation | 21 CFR 872.3710 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EJH clearance
Top EJH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aalba Dent, Inc. | 18 | 2004-03-04 |
| Jeneric Ind. | 12 | 1986-09-02 |
| Jeneric/Pentron, Inc. | 6 | 2000-12-05 |
| Austenal Dental, Inc. | 6 | 1988-04-07 |
| American Dent-All, Inc. | 5 | 2003-03-17 |
58 more applicants have EJH clearances. See the full list in Caduvo.
Most recent EJH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K123929 | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | BEGOPAL+ | 2013-03-14 | 84 |
| K040180 | Aalba Dent, Inc. | CONTINUM V | 2004-03-04 | 37 |
| K040179 | Aalba Dent, Inc. | CONTINUM | 2004-03-03 | 36 |
| K033356 | Aalba Dent, Inc. | VERASOFT ES | 2003-12-30 | 101 |
| K033045 | American Green Dent. Mfg, Inc. | DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST | 2003-12-23 | 85 |
Recalls for EJH devices
openFDA lists no recalls for product code EJH.
Frequently asked questions
What is FDA product code EJH?
EJH is the FDA product code for alloy, metal, base. It is a Class II device, regulated under 21 CFR 872.3710 and reviewed by the Dental panel.
What device class is EJH?
Class II, regulation 21 CFR 872.3710. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EJH?
Across 153 cleared submissions the average was 74 days from receipt to decision (median 54).
Which companies have the most EJH clearances?
Aalba Dent, Inc. (18); Jeneric Ind. (12); Jeneric/Pentron, Inc. (6); Austenal Dental, Inc. (6); American Dent-All, Inc. (5).
Next steps
- Run an FDA pathway report with predicate devices for product code EJH
- Run a recall and safety report across every EJH manufacturer
- Watch product code EJH 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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