FDA product code EKA: File, Margin Finishing, Operative
EKA is the FDA product code for file, 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 EKA, from 2 different applicants. The average 510(k) review took 108 days (median 108).
Classification
| Field | Value |
|---|---|
| Device name | File, 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 EKA clearance
Top EKA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shizai Corp. | 1 | 1983-07-26 |
| U.S. Shizai Corp. | 1 | 1982-11-03 |
Most recent EKA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K830764 | Shizai Corp. | FR ROOT CANAL SEALER | 1983-07-26 | 138 |
| K822464 | U.S. Shizai Corp. | OBTURATION GUTTA | 1982-11-03 | 79 |
Recalls for EKA devices
openFDA lists no recalls for product code EKA.
Frequently asked questions
What is FDA product code EKA?
EKA is the FDA product code for file, 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 EKA?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EKA?
Across 2 cleared submissions the average was 108 days from receipt to decision (median 108).
Which companies have the most EKA clearances?
Shizai Corp. (1); U.S. Shizai Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EKA
- Run a recall and safety report across every EKA manufacturer
- Watch product code EKA 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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