FDA product code EKD: Instrument, Cutting, Operative
EKD is the FDA product code for instrument, cutting, 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 EKD, from 2 different applicants. The average 510(k) review took 44 days (median 44).
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Cutting, 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 EKD clearance
Top EKD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Artiberia | 1 | 1985-07-02 |
| Pacific Dental Corp. | 1 | 1982-07-06 |
Most recent EKD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K851723 | Artiberia | 1300/10 TO 1305/89-92 VARIOUS CUTTING INSTRUMENTS | 1985-07-02 | 68 |
| K821790 | Pacific Dental Corp. | BEACH EXCAVATOR'S NO. 1 & NO. 2 | 1982-07-06 | 19 |
Recalls for EKD devices
openFDA lists no recalls for product code EKD.
Frequently asked questions
What is FDA product code EKD?
EKD is the FDA product code for instrument, cutting, operative. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EKD?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EKD?
Across 2 cleared submissions the average was 44 days from receipt to decision (median 44).
Which companies have the most EKD clearances?
Artiberia (1); Pacific Dental Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EKD
- Run a recall and safety report across every EKD manufacturer
- Watch product code EKD 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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