FDA product code EJW: Clasp, Wire
EJW is the FDA product code for clasp, wire. It is a Class I device, regulated under 21 CFR 872.3285 and reviewed by the Dental panel. FDA has cleared 3 510(k) submissions under EJW, from 3 different applicants. The average 510(k) review took 24 days (median 23).
Classification
| Field | Value |
|---|---|
| Device name | Clasp, Wire |
| Device class | Class I |
| Regulation | 21 CFR 872.3285 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EJW clearance
Top EJW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ivoclar North America, Inc. | 1 | 1990-04-25 |
| Flexmedics | 1 | 1988-04-21 |
| Austenal Dental, Inc. | 1 | 1987-07-21 |
Most recent EJW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K901257 | Ivoclar North America, Inc. | WIRONTOM CLASP WIRE | 1990-04-25 | 41 |
| K881331 | Flexmedics | ORTHODONTIC NITINOL SPRINGS | 1988-04-21 | 23 |
| K872746 | Austenal Dental, Inc. | VITALLIUM WIRE | 1987-07-21 | 8 |
Recalls for EJW devices
openFDA lists no recalls for product code EJW.
Frequently asked questions
What is FDA product code EJW?
EJW is the FDA product code for clasp, wire. It is a Class I device, regulated under 21 CFR 872.3285 and reviewed by the Dental panel.
What device class is EJW?
Class I, regulation 21 CFR 872.3285. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EJW?
Across 3 cleared submissions the average was 24 days from receipt to decision (median 23).
Which companies have the most EJW clearances?
Ivoclar North America, Inc. (1); Flexmedics (1); Austenal Dental, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EJW
- Run a recall and safety report across every EJW manufacturer
- Watch product code EJW 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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