FDA product code ELK: Teeth, Artificial, Backing And Facing
ELK is the FDA product code for teeth, artificial, backing and facing. It is a Class I device, regulated under 21 CFR 872.3910 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under ELK, from 2 different applicants. The average 510(k) review took 48 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Teeth, Artificial, Backing And Facing |
| Device class | Class I |
| Regulation | 21 CFR 872.3910 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every ELK clearance
Top ELK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| J. Aderer, Inc. | 1 | 1981-07-15 |
| Plastics/Packaging | 1 | 1976-12-30 |
Most recent ELK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K811665 | J. Aderer, Inc. | SR-ISOCETTE | 1981-07-15 | 30 |
| K760909 | Plastics/Packaging | THERMOMETER JARS AND CAPS | 1976-12-30 | 65 |
Recalls for ELK devices
openFDA lists no recalls for product code ELK.
Frequently asked questions
What is FDA product code ELK?
ELK is the FDA product code for teeth, artificial, backing and facing. It is a Class I device, regulated under 21 CFR 872.3910 and reviewed by the Dental panel.
What device class is ELK?
Class I, regulation 21 CFR 872.3910. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ELK?
Across 2 cleared submissions the average was 48 days from receipt to decision (median 48).
Which companies have the most ELK clearances?
J. Aderer, Inc. (1); Plastics/Packaging (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ELK
- Run a recall and safety report across every ELK manufacturer
- Watch product code ELK 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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