EFB · Handpiece, Air-Powered, Dental
Dental · 21 CFR 872.4200 · Class 1
Overview
| Product Code | EFB |
|---|---|
| Device Name | Handpiece, Air-Powered, Dental |
| 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 261)
Showing 20 most recent of 261 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251389 | High speed air turbine handpiece | Foshan Topmed Dental Co., Ltd. | Jan 12, 2026 | SESE |
| K251388 | 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 | Synea Fusion Handpieces (Intensiv & Profin) | W&H Dentalwerk Bürmoos GmbH | Feb 28, 2025 | SESE |
| K240337 | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) | Guangdong Jinme Medical Technology Co., Ltd. | Nov 13, 2024 | SESE |
| K241074 | 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 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) | Nakanishi, Inc. | Sep 20, 2024 | SESE |
| K233122 | High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) | Litu Tech , Ltd. | Apr 30, 2024 | SESE |
| K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) | Nakanishi, Inc. | Apr 25, 2024 | SESE |
| K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors | Foshan Coxo Medical Instrument Co., Ltd. | Sep 22, 2023 | SESE |
| K232243 | EVO 700 series high speed handpiece | Ttbio Corp. | Aug 23, 2023 | SESE |
| K230888 | Titanium Turbine | Nakanishi, Inc. | Jun 2, 2023 | SESE |
| K221741 | TRAUS Air Dental Handpiece | Saeshin Precision Co., Ltd. | Feb 22, 2023 | SESE |
| K202674 | Medidenta High Speed Handpieces | Pac-Dent, Inc. | Dec 12, 2022 | SESE |
| K212910 | Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece | Shenzhen Carejoy Technology Co., Ltd. | Nov 17, 2022 | SESE |
| K221548 | Dental Air Polishing Handpiece | Guilin Woodpecker Medical Instrument Co., Ltd. | Sep 28, 2022 | SESE |
| K221814 | OK Handpiece | Jaintek Co.,Ltd | Jul 15, 2022 | SESE |
| K203791 | Stainless Turbine | Nakanishi, Inc. | Jun 21, 2022 | SESE |
| K202371 | Highspeed Airturbine Handpiece | Beijing Dongbo Dental Handpiece Co., Ltd. | Nov 8, 2021 | SESE |
| K202786 | Dental Low-speed Handpieces and Accessories | Microp Technology (Taiwan), Inc. | Sep 3, 2021 | SESE |
| K193264 | 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
- Micro Motors, Inc. — 7 clearances
- Dentsply Intl. — 7 clearances
- E.M.S Electro Medical Systems S.A — 6 clearances
