Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart E — Surgical Devices](/submissions/DE/subpart-e%E2%80%94surgical-devices) → [21 CFR 872.4200](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4200) → EKX — Handpiece, Direct Drive, Ac-Powered # EKX · Handpiece, Direct Drive, Ac-Powered _Dental · 21 CFR 872.4200 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX ## Overview - **Product Code:** EKX - **Device Name:** Handpiece, Direct Drive, Ac-Powered - **Regulation:** [21 CFR 872.4200](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4200) - **Device Class:** 1 - **Review Panel:** [Dental](/submissions/DE) - **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](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX/K252223.md) | Alpha Endo Handpiece (Alpha Endo) | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | Oct 16, 2025 | SESE | | [K251597](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX/K251597.md) | InnerView System | Perimetrics, Inc. | Sep 18, 2025 | SESE | | [K243692](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX/K243692.md) | EnDrive (EnDriveUS) | Advanced Technology Research (A.T.R.) S.R.L. | Aug 22, 2025 | SESE | | [K242514](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX/K242514.md) | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | Shenzhen Rogin Medical Co., Ltd. | Apr 24, 2025 | SESE | | [K241065](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX/K241065.md) | ChecQ (AC100) | Dentis Co., Ltd. | Mar 21, 2025 | SESE | | [K243911](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX/K243911.md) | HPR Cordless Hygiene Handpiece | Handpiece Headquarters | Dec 20, 2024 | SESE | | [K222688](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX/K222688.md) | The Trust | Genoss Co., Ltd. | Aug 9, 2024 | SESE | | [K233865](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX/K233865.md) | X-Smart Pro; X-Smart Pro+ | Dentsply Sirona, Inc. | Jul 24, 2024 | SESE | | [K232551](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX/K232551.md) | EM-07 Cordless Endo Motor | Forum Engineering Technologies (96) , Ltd. | Jul 9, 2024 | SESE | | [K232810](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX/K232810.md) | Dental Handpiece, Wireless Endodontic Handpiece, endoit | Micro-Nx Co., Ltd. | Nov 9, 2023 | SESE | | [K232657](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX/K232657.md) | InnerView LC | Perimetrics, Inc. | Sep 1, 2023 | SESE | | [K220829](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX/K220829.md) | Endo Motor | Foshan Coxo Medical Instrument Co., Ltd. | May 18, 2023 | SESE | | [K222548](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX/K222548.md) | Endo Motor | Shenzhen Perfect Medical Instruments Co., Ltd. | Apr 26, 2023 | SESE | | [K210475](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX/K210475.md) | EQ-M | Meta Systems Co., Ltd. | Sep 21, 2022 | SESE | | [K213897](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX/K213897.md) | Pro M Class | Saeyang Microtech Co., Ltd. | Sep 19, 2022 | SESE | | [K212043](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX/K212043.md) | TRAUS ENDO | Saeshin Precision Co., Ltd. | Jun 24, 2022 | SESE | | [K211531](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX/K211531.md) | Cordless Prophy System, Model: i-Polish | Guilin Woodpecker Medical Instrument Co., Ltd. | Dec 17, 2021 | SESE | | [K203320](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX/K203320.md) | Endo Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | May 10, 2021 | SESE | | [K192649](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX/K192649.md) | Endo Motor | Foshan Cicada Dental Instrument Co, Ltd. | Mar 12, 2021 | SESE | | [K201703](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX/K201703.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com