EKX — Handpiece, Direct Drive, Ac-Powered Class I
FDA Device Classification
Classification Details
- Product Code
- EKX
- Device Class
- Class I
- Regulation Number
- 872.4200
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K252223 | shenzhen superline technology co | Alpha Endo Handpiece (Alpha Endo) | October 16, 2025 |
| K251597 | perimetrics | InnerView System | September 18, 2025 |
| K243692 | advanced technology research (a.t.r.) | EnDrive (EnDriveUS) | August 22, 2025 |
| K242514 | shenzhen rogin medical co | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | April 24, 2025 |
| K241065 | dentis co | ChecQ (AC100) | March 21, 2025 |
| K243911 | handpiece headquarters | HPR Cordless Hygiene Handpiece | December 20, 2024 |
| K222688 | genoss co | The Trust | August 9, 2024 |
| K233865 | dentsply sirona | X-Smart Pro; X-Smart Pro+ | July 24, 2024 |
| K232551 | forum engineering technologies (96) | EM-07 Cordless Endo Motor | July 9, 2024 |
| K232810 | micro-nx co | Dental Handpiece, Wireless Endodontic Handpiece, endoit | November 9, 2023 |
| K232657 | perimetrics | InnerView LC | September 1, 2023 |
| K220829 | foshan coxo medical instrument co | Endo Motor | May 18, 2023 |
| K222548 | shenzhen perfect medical instruments co | Endo Motor | April 26, 2023 |
| K210475 | meta systems co | EQ-M | September 21, 2022 |
| K213897 | saeyang microtech co | Pro M Class | September 19, 2022 |
| K212043 | saeshin precision co | TRAUS ENDO | June 24, 2022 |
| K211531 | guilin woodpecker medical instrument co | Cordless Prophy System, Model: i-Polish | December 17, 2021 |
| K203320 | guilin woodpecker medical instrument co | Endo Motor | May 10, 2021 |
| K192649 | foshan cicada dental instrument co | Endo Motor | March 12, 2021 |
| K201703 | w and h dentalwerk buermoos | PROXEO Twist Cordless Polishing System PL-40 H | February 24, 2021 |