FDA product code EJZ: Knife, Margin Finishing, Operative
EJZ is the FDA product code for knife, margin finishing, 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 EJZ, from 2 different applicants. The average 510(k) review took 56 days (median 56).
Classification
| Field | Value |
|---|---|
| Device name | Knife, Margin Finishing, 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 EJZ clearance
Top EJZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wonder Wire | 1 | 1987-10-09 |
| Miltex, Inc. | 1 | 1982-11-24 |
Most recent EJZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K872622 | Wonder Wire | ORTHODONTIC ARCH | 1987-10-09 | 95 |
| K823315 | Miltex, Inc. | DENTAL INSTRUMENTS - KNIVES | 1982-11-24 | 16 |
Recalls for EJZ devices
openFDA lists no recalls for product code EJZ.
Frequently asked questions
What is FDA product code EJZ?
EJZ is the FDA product code for knife, margin finishing, operative. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EJZ?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EJZ?
Across 2 cleared submissions the average was 56 days from receipt to decision (median 56).
Which companies have the most EJZ clearances?
Wonder Wire (1); Miltex, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EJZ
- Run a recall and safety report across every EJZ manufacturer
- Watch product code EJZ 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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