EKX
- Product code
- EKX
- Device name
- Handpiece, Direct Drive, Ac-Powered
- Device class
- Class 1
- 21 CFR
- 21 CFR 872.4200
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 10
- Summaries archived here
- 6 (direct download)
- 510(k) clearances (all years, FDA)
- 89 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (10)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252223 | 2025-10-16 | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD… | Alpha Endo Handpiece (Alpha Endo) | |
| K251597 | 2025-09-18 | Perimetrics, Inc. | InnerView System | FDA |
| K243692 | 2025-08-22 | Advanced Technology Research (A.T.R.) … | EnDrive (EnDriveUS) | |
| K242514 | 2025-04-24 | Shenzhen Rogin Medical Co., Ltd. | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | |
| K241065 | 2025-03-21 | Dentis Co., Ltd. | ChecQ (AC100) | |
| K243911 | 2024-12-20 | Handpiece Headquarters | HPR Cordless Hygiene Handpiece | — |
| K222688 | 2024-08-09 | Genoss Co., Ltd. | The Trust | |
| K233865 | 2024-07-24 | Dentsply Sirona, Inc. | X-Smart Pro; X-Smart Pro+ | |
| K232551 | 2024-07-09 | Forum Engineering Technologies (96) , … | EM-07 Cordless Endo Motor | — |
| K232810 | 2023-11-09 | Micro-Nx Co., Ltd. | Dental Handpiece, Wireless Endodontic Handpiece, end… | FDA |
Official FDA classification page: EKX
Classification and pathway per current FDA publications. Data from openFDA (CC0).