FDA product code EEJ: Guard, Disk
EEJ is the FDA product code for guard, disk. It is a Class I device, regulated under 21 CFR 872.6010 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under EEJ. The average 510(k) review took 126 days (median 126).
Classification
| Field | Value |
|---|---|
| Device name | Guard, Disk |
| Device class | Class I |
| Regulation | 21 CFR 872.6010 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every EEJ clearance
Top EEJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nortex USA, Inc. | 1 | 1986-03-12 |
Most recent EEJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K854467 | Nortex USA, Inc. | S.T.P.B SOFT TISSUES PROTECTIVES BLADES | 1986-03-12 | 126 |
Recalls for EEJ devices
openFDA lists no recalls for product code EEJ.
Frequently asked questions
What is FDA product code EEJ?
EEJ is the FDA product code for guard, disk. It is a Class I device, regulated under 21 CFR 872.6010 and reviewed by the Dental panel.
What device class is EEJ?
Class I, regulation 21 CFR 872.6010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EEJ?
Across 1 cleared submissions the average was 126 days from receipt to decision (median 126).
Which companies have the most EEJ clearances?
Nortex USA, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EEJ
- Run a recall and safety report across every EEJ manufacturer
- Watch product code EEJ 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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