FDA product code EKY: Handpiece, Water-Powered
EKY is the FDA product code for handpiece, water-powered. It is a Class I device, regulated under 21 CFR 872.4200 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under EKY, from 2 different applicants. The average 510(k) review took 135 days (median 135).
Classification
| Field | Value |
|---|---|
| Device name | Handpiece, Water-Powered |
| Device class | Class I |
| Regulation | 21 CFR 872.4200 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every EKY clearance
Top EKY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Saeshin Precision Co., Ltd. | 1 | 2012-12-18 |
| Nevin Laboratories, Inc. | 1 | 1990-07-19 |
Most recent EKY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K123695 | Saeshin Precision Co., Ltd. | TRAUS SIP10 | 2012-12-18 | 15 |
| K896364 | Nevin Laboratories, Inc. | DECIDENT | 1990-07-19 | 255 |
Recalls for EKY devices
openFDA lists no recalls for product code EKY.
Frequently asked questions
What is FDA product code EKY?
EKY is the FDA product code for handpiece, water-powered. It is a Class I device, regulated under 21 CFR 872.4200 and reviewed by the Dental panel.
What device class is EKY?
Class I, regulation 21 CFR 872.4200. Typical premarket route: 510(k).
How long does a 510(k) take for product code EKY?
Across 2 cleared submissions the average was 135 days from receipt to decision (median 135).
Which companies have the most EKY clearances?
Saeshin Precision Co., Ltd. (1); Nevin Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EKY
- Run a recall and safety report across every EKY manufacturer
- Watch product code EKY 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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