FDA product code ELN: Teeth, Preformed Gold Denture
ELN is the FDA product code for teeth, preformed gold denture. It is a Class I device, regulated under 21 CFR 872.3580 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under ELN. The average 510(k) review took 19 days (median 19).
Classification
| Field | Value |
|---|---|
| Device name | Teeth, Preformed Gold Denture |
| Device class | Class I |
| Regulation | 21 CFR 872.3580 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every ELN clearance
Top ELN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Espe GmbH (Us) | 1 | 1977-06-01 |
Most recent ELN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K770872 | Espe GmbH (Us) | IMPRESSION MATERIAL, ALGINATE | 1977-06-01 | 19 |
Recalls for ELN devices
openFDA lists no recalls for product code ELN.
Frequently asked questions
What is FDA product code ELN?
ELN is the FDA product code for teeth, preformed gold denture. It is a Class I device, regulated under 21 CFR 872.3580 and reviewed by the Dental panel.
What device class is ELN?
Class I, regulation 21 CFR 872.3580. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ELN?
Across 1 cleared submissions the average was 19 days from receipt to decision (median 19).
Which companies have the most ELN clearances?
Espe GmbH (Us) (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ELN
- Run a recall and safety report across every ELN manufacturer
- Watch product code ELN 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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