EFB
- Product code
- EFB
- Device name
- Handpiece, Air-Powered, Dental
- 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
- 8 (direct download)
- 510(k) clearances (all years, FDA)
- 261 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (9)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251389 | 2026-01-12 | Foshan Topmed Dental Co., Ltd. | High speed air turbine handpiece | |
| K251388 | 2026-01-12 | Foshan Topmed Dental Co., Ltd. | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-2… | |
| K242179 | 2025-02-28 | W&H Dentalwerk Bürmoos GmbH | Synea Fusion Handpieces (Intensiv & Profin) | FDA |
| K240337 | 2024-11-13 | Guangdong Jinme Medical Technology Co.… | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH1… | |
| K241074 | 2024-11-12 | Foshan Soco Precision Instrument Co., … | High-speed Air Turbine Handpieces (SCHG01, SCHG03, S… | |
| K241880 | 2024-09-20 | Nakanishi, Inc. | Air Powered Tooth Polishing System (Perio-Mate); Air… | |
| K233122 | 2024-04-30 | Litu Tech , Ltd. | High Speed Air Turbine Handpiece (G100,G200,G300,G40… | |
| K233308 | 2024-04-25 | Nakanishi, Inc. | Air Motor (Model name: FX204 M4); Air Motor (Model n… | |
| K220179 | 2023-09-22 | Foshan Coxo Medical Instrument Co., Lt… | High-Speed Air Turbine Handpieces/Straight Handpiece… |
Official FDA classification page: EFB
Classification and pathway per current FDA publications. Data from openFDA (CC0).