FDA product code EJE: Frame, Rubber Dam
EJE is the FDA product code for frame, rubber dam. It is a Class I device, regulated under 21 CFR 872.6300 and reviewed by the Dental panel. FDA has cleared 3 510(k) submissions under EJE, from 2 different applicants. The average 510(k) review took 25 days (median 29).
Classification
| Field | Value |
|---|---|
| Device name | Frame, Rubber Dam |
| Device class | Class I |
| Regulation | 21 CFR 872.6300 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every EJE clearance
Top EJE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hygienic Dental Mfg., Co., The | 2 | 1978-05-12 |
| Young Dental Manufacturing Co. 1, LLC | 1 | 1978-10-10 |
Most recent EJE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K781520 | Young Dental Manufacturing Co. 1, LLC | RUBBER DAM HOLDER | 1978-10-10 | 39 |
| K780746 | Hygienic Dental Mfg., Co., The | HYGIENIC RUBBER DAM FRAME | 1978-05-12 | 29 |
| K770117 | Hygienic Dental Mfg., Co., The | HYGIENIC 5 & 6 RUBBER DAM FRAME | 1977-01-28 | 7 |
Recalls for EJE devices
openFDA lists no recalls for product code EJE.
Frequently asked questions
What is FDA product code EJE?
EJE is the FDA product code for frame, rubber dam. It is a Class I device, regulated under 21 CFR 872.6300 and reviewed by the Dental panel.
What device class is EJE?
Class I, regulation 21 CFR 872.6300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EJE?
Across 3 cleared submissions the average was 25 days from receipt to decision (median 29).
Which companies have the most EJE clearances?
Hygienic Dental Mfg., Co., The (2); Young Dental Manufacturing Co. 1, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EJE
- Run a recall and safety report across every EJE manufacturer
- Watch product code EJE 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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