FDA product code EBW: Controller, Foot, Handpiece And Cord
EBW is the FDA product code for controller, foot, handpiece and cord. It is a Class I device, regulated under 21 CFR 872.4200 and reviewed by the Dental panel. FDA has cleared 61 510(k) submissions under EBW, 15 in the last five years, from 40 different applicants. The average 510(k) review took 212 days (median 180); 298 days on average over the last three years. FDA has posted 2 recalls for EBW devices.
Classification
| Field | Value |
|---|---|
| Device name | Controller, Foot, Handpiece And Cord |
| Device class | Class I |
| Regulation | 21 CFR 872.4200 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for EBW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 208 |
| 2018 | 1 | 179 |
| 2019 | 2 | 368 |
| 2020 | 1 | 276 |
| 2021 | 2 | 328 |
| 2022 | 6 | 436 |
| 2024 | 4 | 290 |
| 2025 | 3 | 358 |
| 2026 | 2 | 246 |
Compare with all 510(k) review times · Search every EBW clearance
Top EBW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nakanishi, Inc. | 7 | 2024-06-24 |
| W&H Dentalwerk Buermoos GmbH | 5 | 2019-03-26 |
| Saeshin Precision Co., Ltd. | 3 | 2026-01-30 |
| Micro-Nx Co., Ltd. | 3 | 2025-07-18 |
| Cefla S.C. | 2 | 2024-04-01 |
35 more applicants have EBW clearances. See the full list in Caduvo.
Most recent EBW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251407 | Saeshin Precision Co., Ltd. | Motor Handpiece and Control Unit (SDI10) | 2026-01-30 | 269 |
| K251701 | Dentalez, Inc., Stardental Division | Star E900 Electric System | 2026-01-12 | 224 |
| K251811 | Dentsply Sirona, Inc. | Motor and Apex Module (MaAM) | 2025-08-25 | 74 |
| K231562 | Micro-Nx Co., Ltd. | ELEC ENGINE (Model: ISE-170L) | 2025-07-18 | 779 |
| K242646 | Guilin Aesthedent Medical Instruments Co., Ltd. | Dental Implant Unit | 2025-04-11 | 220 |
Recalls for EBW devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-12-21.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code EBW?
EBW is the FDA product code for controller, foot, handpiece and cord. It is a Class I device, regulated under 21 CFR 872.4200 and reviewed by the Dental panel.
What device class is EBW?
Class I, regulation 21 CFR 872.4200. Typical premarket route: 510(k).
How long does a 510(k) take for product code EBW?
Across 61 cleared submissions the average was 212 days from receipt to decision (median 180).
Which companies have the most EBW clearances?
Nakanishi, Inc. (7); W&H Dentalwerk Buermoos GmbH (5); Saeshin Precision Co., Ltd. (3); Micro-Nx Co., Ltd. (3); Cefla S.C. (2).
Have EBW devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2017-12-21.
Next steps
- Run an FDA pathway report with predicate devices for product code EBW
- Run a recall and safety report across every EBW manufacturer
- Watch product code EBW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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