FDA product code EKX: Handpiece, Direct Drive, Ac-Powered
EKX is the FDA product code for handpiece, direct drive, ac-powered. It is a Class I device, regulated under 21 CFR 872.4200 and reviewed by the Dental panel. FDA has cleared 90 510(k) submissions under EKX, 17 in the last five years, from 58 different applicants. The average 510(k) review took 182 days (median 128); 204 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Handpiece, Direct Drive, Ac-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 |
510(k) clearances per year for EKX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 245 |
| 2018 | 3 | 279 |
| 2019 | 3 | 356 |
| 2020 | 1 | 414 |
| 2021 | 5 | 274 |
| 2022 | 3 | 406 |
| 2023 | 4 | 182 |
| 2024 | 4 | 314 |
| 2025 | 5 | 211 |
| 2026 | 1 | 88 |
Compare with all 510(k) review times · Search every EKX clearance
Top EKX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| J. Morita USA, Inc. | 6 | 2018-10-11 |
| Osstell AB | 5 | 2026-09-08 |
| Aseptico, Inc. | 5 | 2015-05-28 |
| Perimetrics, Inc. | 3 | 2025-09-18 |
| Saeshin Precision Co., Ltd. | 3 | 2022-06-24 |
53 more applicants have EKX clearances. See the full list in Caduvo.
Most recent EKX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261987 | Osstell AB | Reusable SmartPeg | 2026-09-08 | 88 |
| K252223 | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | Alpha Endo Handpiece (Alpha Endo) | 2025-10-16 | 92 |
| K251597 | Perimetrics, Inc. | InnerView System | 2025-09-18 | 114 |
| K243692 | Advanced Technology Research (A.T.R.) S.R.L. | EnDrive (EnDriveUS) | 2025-08-22 | 266 |
| K242514 | Shenzhen Rogin Medical Co., Ltd. | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | 2025-04-24 | 244 |
Recalls for EKX devices
openFDA lists no recalls for product code EKX.
Frequently asked questions
What is FDA product code EKX?
EKX is the FDA product code for handpiece, direct drive, ac-powered. It is a Class I device, regulated under 21 CFR 872.4200 and reviewed by the Dental panel.
What device class is EKX?
Class I, regulation 21 CFR 872.4200. Typical premarket route: 510(k).
How long does a 510(k) take for product code EKX?
Across 90 cleared submissions the average was 182 days from receipt to decision (median 128).
Which companies have the most EKX clearances?
J. Morita USA, Inc. (6); Osstell AB (5); Aseptico, Inc. (5); Perimetrics, Inc. (3); Saeshin Precision Co., Ltd. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code EKX
- Run a recall and safety report across every EKX manufacturer
- Watch product code EKX 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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