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) → EFB — Handpiece, Air-Powered, Dental # EFB · Handpiece, Air-Powered, Dental _Dental · 21 CFR 872.4200 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB ## Overview - **Product Code:** EFB - **Device Name:** Handpiece, Air-Powered, Dental - **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 261) Showing 20 most recent of 261 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251389](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K251389.md) | High speed air turbine handpiece | Foshan Topmed Dental Co., Ltd. | Jan 12, 2026 | SESE | | [K251388](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K251388.md) | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) | Foshan Topmed Dental Co., Ltd. | Jan 12, 2026 | SESE | | [K242179](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K242179.md) | Synea Fusion Handpieces (Intensiv & Profin) | W&H Dentalwerk Bürmoos GmbH | Feb 28, 2025 | SESE | | [K240337](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K240337.md) | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) | Guangdong Jinme Medical Technology Co., Ltd. | Nov 13, 2024 | SESE | | [K241074](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K241074.md) | High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) | Foshan Soco Precision Instrument Co., Ltd. | Nov 12, 2024 | SESE | | [K241880](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K241880.md) | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) | Nakanishi, Inc. | Sep 20, 2024 | SESE | | [K233122](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K233122.md) | High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) | Litu Tech , Ltd. | Apr 30, 2024 | SESE | | [K233308](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K233308.md) | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) | Nakanishi, Inc. | Apr 25, 2024 | SESE | | [K220179](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K220179.md) | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors | Foshan Coxo Medical Instrument Co., Ltd. | Sep 22, 2023 | SESE | | [K232243](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K232243.md) | EVO 700 series high speed handpiece | Ttbio Corp. | Aug 23, 2023 | SESE | | [K230888](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K230888.md) | Titanium Turbine | Nakanishi, Inc. | Jun 2, 2023 | SESE | | [K221741](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K221741.md) | TRAUS Air Dental Handpiece | Saeshin Precision Co., Ltd. | Feb 22, 2023 | SESE | | [K202674](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K202674.md) | Medidenta High Speed Handpieces | Pac-Dent, Inc. | Dec 12, 2022 | SESE | | [K212910](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K212910.md) | Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece | Shenzhen Carejoy Technology Co., Ltd. | Nov 17, 2022 | SESE | | [K221548](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K221548.md) | Dental Air Polishing Handpiece | Guilin Woodpecker Medical Instrument Co., Ltd. | Sep 28, 2022 | SESE | | [K221814](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K221814.md) | OK Handpiece | Jaintek Co.,Ltd | Jul 15, 2022 | SESE | | [K203791](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K203791.md) | Stainless Turbine | Nakanishi, Inc. | Jun 21, 2022 | SESE | | [K202371](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K202371.md) | Highspeed Airturbine Handpiece | Beijing Dongbo Dental Handpiece Co., Ltd. | Nov 8, 2021 | SESE | | [K202786](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K202786.md) | Dental Low-speed Handpieces and Accessories | Microp Technology (Taiwan), Inc. | Sep 3, 2021 | SESE | | [K193264](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB/K193264.md) | Disposable High Speed Air Turbine Handpiece | Ningbo Hpdove Dental Instruments Co., Ltd. | Aug 11, 2020 | SESE | ## Top Applicants - A-Dec, Inc. — 19 clearances - Nakanishi, Inc. — 10 clearances - Dentsply Intl. — 7 clearances - Micro Motors, Inc. — 7 clearances - Dentalez, Inc. — 6 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EFB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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