FDA product code EJY: Pliers, Operative
EJY is the FDA product code for pliers, operative. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under EJY, from 2 different applicants. The average 510(k) review took 44 days (median 44).
Classification
| Field | Value |
|---|---|
| Device name | Pliers, Operative |
| Device class | Class I |
| Regulation | 21 CFR 872.4565 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EJY clearance
Top EJY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Artiberia | 1 | 1985-07-02 |
| Pacific Dental Corp. | 1 | 1982-07-06 |
Most recent EJY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K851730 | Artiberia | 2710 TO 2935 VARIOUS PLIERS FOR ORTHODONTICS/PROST | 1985-07-02 | 68 |
| K821787 | Pacific Dental Corp. | BEACH SURGICAL PLIERS NON-HOOK | 1982-07-06 | 19 |
Recalls for EJY devices
openFDA lists no recalls for product code EJY.
Frequently asked questions
What is FDA product code EJY?
EJY is the FDA product code for pliers, operative. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EJY?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EJY?
Across 2 cleared submissions the average was 44 days from receipt to decision (median 44).
Which companies have the most EJY clearances?
Artiberia (1); Pacific Dental Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EJY
- Run a recall and safety report across every EJY manufacturer
- Watch product code EJY 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.
All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times