FDA product code EFB: Handpiece, Air-Powered, Dental
EFB is the FDA product code for handpiece, air-powered, dental. It is a Class I device, regulated under 21 CFR 872.4200 and reviewed by the Dental panel. FDA has cleared 261 510(k) submissions under EFB, 17 in the last five years, from 144 different applicants. The average 510(k) review took 166 days (median 104); 223 days on average over the last three years. FDA has posted 8 recalls for EFB devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Handpiece, Air-Powered, Dental |
| 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 EFB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 7 | 237 |
| 2018 | 3 | 224 |
| 2019 | 3 | 381 |
| 2020 | 5 | 316 |
| 2021 | 2 | 396 |
| 2022 | 5 | 387 |
| 2023 | 4 | 238 |
| 2024 | 5 | 200 |
| 2025 | 1 | 218 |
| 2026 | 2 | 252 |
Compare with all 510(k) review times · Search every EFB clearance
Top EFB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| A-Dec, Inc. | 19 | 2009-01-15 |
| Nakanishi, Inc. | 10 | 2024-09-20 |
| Dentsply Intl. | 7 | 2004-06-16 |
| Micro Motors, Inc. | 7 | 1997-03-31 |
| Dentalez, Inc. | 6 | 2020-01-06 |
139 more applicants have EFB clearances. See the full list in Caduvo.
Most recent EFB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251388 | Foshan Topmed Dental Co., Ltd. | 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) | 2026-01-12 | 252 |
| K251389 | Foshan Topmed Dental Co., Ltd. | High speed air turbine handpiece | 2026-01-12 | 252 |
| K242179 | W&H Dentalwerk Bürmoos GmbH | Synea Fusion Handpieces (Intensiv & Profin) | 2025-02-28 | 218 |
| K240337 | Guangdong Jinme Medical Technology Co., Ltd. | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) | 2024-11-13 | 282 |
| K241074 | Foshan Soco Precision Instrument Co., Ltd. | 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) | 2024-11-12 | 207 |
Recalls for EFB devices
8 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-01-20.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code EFB?
EFB is the FDA product code for handpiece, air-powered, dental. It is a Class I device, regulated under 21 CFR 872.4200 and reviewed by the Dental panel.
What device class is EFB?
Class I, regulation 21 CFR 872.4200. Typical premarket route: 510(k).
How long does a 510(k) take for product code EFB?
Across 261 cleared submissions the average was 166 days from receipt to decision (median 104).
Which companies have the most EFB clearances?
A-Dec, Inc. (19); Nakanishi, Inc. (10); Dentsply Intl. (7); Micro Motors, Inc. (7); Dentalez, Inc. (6).
Have EFB devices been recalled?
Yes: 8 product recalls across 5 recall events; the most recent began 2023-01-20.
Next steps
- Run an FDA pathway report with predicate devices for product code EFB
- Run a recall and safety report across every EFB manufacturer
- Watch product code EFB 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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