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) → EBW — Controller, Foot, Handpiece And Cord # EBW · Controller, Foot, Handpiece And Cord _Dental · 21 CFR 872.4200 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW ## Overview - **Product Code:** EBW - **Device Name:** Controller, Foot, Handpiece And Cord - **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 61) Showing 20 most recent of 61 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251407](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K251407.md) | Motor Handpiece and Control Unit (SDI10) | Saeshin Precision Co., Ltd. | Jan 30, 2026 | SESE | | [K251701](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K251701.md) | Star E900 Electric System | Dentalez, Inc., Stardental Division | Jan 12, 2026 | SESE | | [K251811](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K251811.md) | Motor and Apex Module (MaAM) | Dentsply Sirona, Inc. | Aug 25, 2025 | SESE | | [K231562](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K231562.md) | ELEC ENGINE (Model: ISE-170L) | Micro-Nx Co., Ltd. | Jul 18, 2025 | SESE | | [K242646](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K242646.md) | Dental Implant Unit | Guilin Aesthedent Medical Instruments Co., Ltd. | Apr 11, 2025 | SESE | | [K233288](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K233288.md) | NLZ Built-In Motor System | Nakanishi, Inc. | Jun 24, 2024 | SESE | | [K233117](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K233117.md) | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) | Nakanishi, Inc. | Jun 20, 2024 | SESE | | [K230895](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K230895.md) | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4, | Cefla S.C. | Apr 1, 2024 | SESE | | [K231864](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K231864.md) | Fiber Optic Brushless Electronic Micromotor, model: iM100 | Codent Technical Industry Co., Ltd. | Mar 11, 2024 | SESE | | [K211358](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K211358.md) | Implanter incl. Accessories | Guilin Woodpecker Medical Instrument Co., Ltd. | Nov 21, 2022 | SESE | | [K220831](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K220831.md) | Dental Implantation Systems, Dental Electrical Motors | Foshan Coxo Medical Instrument Co., Ltd. | Sep 27, 2022 | SESE | | [K213022](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K213022.md) | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED | Cefla S.C. | May 9, 2022 | SESE | | [K202075](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K202075.md) | Dental Electric Motor | Foshan Cicada Dental Instrument Co, Ltd. | Mar 11, 2022 | SESE | | [K201191](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K201191.md) | ELEC-LED | Micro-Nx Co., Ltd. | Feb 7, 2022 | SESE | | [K203706](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K203706.md) | Dental Electric Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | Jan 13, 2022 | SESE | | [K201192](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K201192.md) | Impla-NX (Model: ISE-270M) | Micro-Nx Co., Ltd. | May 21, 2021 | SESE | | [K201292](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K201292.md) | TRAUS SIP20 | Saeshin Precision Co., Ltd. | Feb 11, 2021 | SESE | | [K193341](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K193341.md) | iCTmotor (WL-1) | Dentium Co., Ltd. | Sep 4, 2020 | SESE | | [K180845](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K180845.md) | Maxima Electric System | Handpiece Headquarters - Hpr, Inc. | Jul 25, 2019 | SESE | | [K181858](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K181858.md) | Electric Handpiece Motor | W&H Dentalwerk Buermoos GmbH | Mar 26, 2019 | SESE | ## Top Applicants - Nakanishi, Inc. — 7 clearances - W&H Dentalwerk Buermoos GmbH — 5 clearances - Micro-Nx Co., Ltd. — 3 clearances - Saeshin Precision Co., Ltd. — 3 clearances - A-Dec, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW) **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