FDA product code EJX: Anchor, Preformed
EJX is the FDA product code for anchor, preformed. It is a Class I device, regulated under 21 CFR 872.3130 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under EJX. The average 510(k) review took 459 days (median 459).
Classification
| Field | Value |
|---|---|
| Device name | Anchor, Preformed |
| Device class | Class I |
| Regulation | 21 CFR 872.3130 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EJX clearance
Top EJX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| M&M Dental Studio, Inc. | 1 | 2015-01-02 |
Most recent EJX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K133088 | M&M Dental Studio, Inc. | ZX-27 | 2015-01-02 | 459 |
Recalls for EJX devices
openFDA lists no recalls for product code EJX.
Frequently asked questions
What is FDA product code EJX?
EJX is the FDA product code for anchor, preformed. It is a Class I device, regulated under 21 CFR 872.3130 and reviewed by the Dental panel.
What device class is EJX?
Class I, regulation 21 CFR 872.3130. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EJX?
Across 1 cleared submissions the average was 459 days from receipt to decision (median 459).
Which companies have the most EJX clearances?
M&M Dental Studio, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EJX
- Run a recall and safety report across every EJX manufacturer
- Watch product code EJX 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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