EKX · Handpiece, Direct Drive, Ac-Powered
Dental · 21 CFR 872.4200 · Class 1
Overview
| Product Code | EKX |
|---|---|
| Device Name | Handpiece, Direct Drive, Ac-Powered |
| Regulation | 21 CFR 872.4200 |
| Device Class | Class 1 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.
Classification Rationale
Class I.
Recent Cleared Devices (20 of 89)
Showing 20 most recent of 89 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252223 | Alpha Endo Handpiece (Alpha Endo) | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | Oct 16, 2025 | SESE |
| K251597 | InnerView System | Perimetrics, Inc. | Sep 18, 2025 | SESE |
| K243692 | EnDrive (EnDriveUS) | Advanced Technology Research (A.T.R.) S.R.L. | Aug 22, 2025 | SESE |
| K242514 | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | Shenzhen Rogin Medical Co., Ltd. | Apr 24, 2025 | SESE |
| K241065 | ChecQ (AC100) | Dentis Co., Ltd. | Mar 21, 2025 | SESE |
| K243911 | HPR Cordless Hygiene Handpiece | Handpiece Headquarters | Dec 20, 2024 | SESE |
| K222688 | The Trust | Genoss Co., Ltd. | Aug 9, 2024 | SESE |
| K233865 | X-Smart Pro; X-Smart Pro+ | Dentsply Sirona, Inc. | Jul 24, 2024 | SESE |
| K232551 | EM-07 Cordless Endo Motor | Forum Engineering Technologies (96) , Ltd. | Jul 9, 2024 | SESE |
| K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | Micro-Nx Co., Ltd. | Nov 9, 2023 | SESE |
| K232657 | InnerView LC | Perimetrics, Inc. | Sep 1, 2023 | SESE |
| K220829 | Endo Motor | Foshan Coxo Medical Instrument Co., Ltd. | May 18, 2023 | SESE |
| K222548 | Endo Motor | Shenzhen Perfect Medical Instruments Co., Ltd. | Apr 26, 2023 | SESE |
| K210475 | EQ-M | Meta Systems Co., Ltd. | Sep 21, 2022 | SESE |
| K213897 | Pro M Class | Saeyang Microtech Co., Ltd. | Sep 19, 2022 | SESE |
| K212043 | TRAUS ENDO | Saeshin Precision Co., Ltd. | Jun 24, 2022 | SESE |
| K211531 | Cordless Prophy System, Model: i-Polish | Guilin Woodpecker Medical Instrument Co., Ltd. | Dec 17, 2021 | SESE |
| K203320 | Endo Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | May 10, 2021 | SESE |
| K192649 | Endo Motor | Foshan Cicada Dental Instrument Co, Ltd. | Mar 12, 2021 | SESE |
| K201703 | PROXEO Twist Cordless Polishing System PL-40 H | W&H Dentalwerk Buermoos GmbH | Feb 24, 2021 | SESE |
Top Applicants
- J. Morita USA, Inc. — 6 clearances
- Aseptico, Inc. — 5 clearances
- Osstell AB — 4 clearances
- W&H Dentalwerk Buermoos GmbH — 3 clearances
- Saeshin Precision Co., Ltd. — 3 clearances
