EBW · Controller, Foot, Handpiece And Cord
Dental · 21 CFR 872.4200 · Class 1
Overview
| Product Code | EBW |
|---|---|
| Device Name | Controller, Foot, Handpiece And Cord |
| 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 61)
Showing 20 most recent of 61 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251407 | Motor Handpiece and Control Unit (SDI10) | Saeshin Precision Co., Ltd. | Jan 30, 2026 | SESE |
| K251701 | Star E900 Electric System | Dentalez, Inc., Stardental Division | Jan 12, 2026 | SESE |
| K251811 | Motor and Apex Module (MaAM) | Dentsply Sirona, Inc. | Aug 25, 2025 | SESE |
| K231562 | ELEC ENGINE (Model: ISE-170L) | Micro-Nx Co., Ltd. | Jul 18, 2025 | SESE |
| K242646 | Dental Implant Unit | Guilin Aesthedent Medical Instruments Co., Ltd. | Apr 11, 2025 | SESE |
| K233288 | NLZ Built-In Motor System | Nakanishi, Inc. | Jun 24, 2024 | SESE |
| K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) | Nakanishi, Inc. | Jun 20, 2024 | SESE |
| K230895 | 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 | Fiber Optic Brushless Electronic Micromotor, model: iM100 | Codent Technical Industry Co., Ltd. | Mar 11, 2024 | SESE |
| K211358 | Implanter incl. Accessories | Guilin Woodpecker Medical Instrument Co., Ltd. | Nov 21, 2022 | SESE |
| K220831 | Dental Implantation Systems, Dental Electrical Motors | Foshan Coxo Medical Instrument Co., Ltd. | Sep 27, 2022 | SESE |
| K213022 | 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 | Dental Electric Motor | Foshan Cicada Dental Instrument Co, Ltd. | Mar 11, 2022 | SESE |
| K201191 | ELEC-LED | Micro-Nx Co., Ltd. | Feb 7, 2022 | SESE |
| K203706 | Dental Electric Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | Jan 13, 2022 | SESE |
| K201192 | Impla-NX (Model: ISE-270M) | Micro-Nx Co., Ltd. | May 21, 2021 | SESE |
| K201292 | TRAUS SIP20 | Saeshin Precision Co., Ltd. | Feb 11, 2021 | SESE |
| K193341 | iCTmotor (WL-1) | Dentium Co., Ltd. | Sep 4, 2020 | SESE |
| K180845 | Maxima Electric System | Handpiece Headquarters - Hpr, Inc. | Jul 25, 2019 | SESE |
| K181858 | 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
