EBW
- Product code
- EBW
- Device name
- Controller, Foot, Handpiece And Cord
- Device class
- Class 1
- 21 CFR
- 21 CFR 872.4200
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 9
- Summaries archived here
- 9 (direct download)
- 510(k) clearances (all years, FDA)
- 61 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (9)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251407 | 2026-01-30 | Saeshin Precision Co., Ltd. | Motor Handpiece and Control Unit (SDI10) | |
| K251701 | 2026-01-12 | Dentalez, Inc., Stardental Division | Star E900 Electric System | |
| K251811 | 2025-08-25 | Dentsply Sirona, Inc. | Motor and Apex Module (MaAM) | |
| K231562 | 2025-07-18 | Micro-Nx Co., Ltd. | ELEC ENGINE (Model: ISE-170L) | |
| K242646 | 2025-04-11 | Guilin Aesthedent Medical Instruments | Dental Implant Unit | |
| K233288 | 2024-06-24 | Nakanishi, Inc. | NLZ Built-In Motor System | |
| K233117 | 2024-06-20 | Nakanishi, Inc. | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic P | |
| K230895 | 2024-04-01 | Cefla S.C. | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FL | |
| K231864 | 2024-03-11 | Codent Technical Industry Co., Ltd. | Fiber Optic Brushless Electronic Micromotor, model: |
Official FDA classification page: EBW
Classification and pathway per current FDA publications. Data from openFDA (CC0).