EFB · Class I · 21 CFR 872.4200

FDA Product Code EFB: Handpiece, Air-powered, Dental

FDA product code EFB covers air-powered dental handpieces used for cutting, drilling, and polishing in dental procedures.

These high-speed instruments use compressed air to rotate dental burs and attachments at speeds up to 400,000 RPM for efficient tooth preparation, cavity removal, and crown and bridge preparation. They are the most widely used dental instrument in clinical practice.

EFB devices are Class I medical devices, regulated under 21 CFR 872.4200 and reviewed by the FDA Dental panel.

Leading manufacturers include Dentsply Intl., Nakanishi, Inc. and Beijing Dongbo Dental Handpiece Co., Ltd..

261
Total
261
Cleared
166d
Avg days
1976
Since
Declining activity - 6 submissions in the last 2 years vs 10 in the prior period
Review times increasing: avg 216d recently vs 164d historically

FDA 510(k) Cleared Handpiece, Air-powered, Dental Devices (Product Code EFB)

261 devices
1–24 of 261
Cleared Jan 12, 2026
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)
K251388
Foshan Topmed Dental Co., Ltd.
Dental · 252d
Cleared Jan 12, 2026
High speed air turbine handpiece
K251389
Foshan Topmed Dental Co., Ltd.
Dental · 252d
Cleared Feb 28, 2025
Synea Fusion Handpieces (Intensiv & Profin)
K242179
W&H Dentalwerk B?rmoos GmbH
Dental · 218d
Cleared Nov 13, 2024
Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
K240337
Guangdong Jinme Medical Technology Co., Ltd.
Dental · 282d
Cleared Nov 12, 2024
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)
K241074
Foshan Soco Precision Instrument Co., Ltd.
Dental · 207d
Cleared Sep 20, 2024
Air Powered Tooth Polishing System (Perio-Mate)
K241880
Nakanishi, Inc.
Dental · 84d
Cleared Apr 30, 2024
High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)
K233122
Litu Tech , Ltd.
Dental · 216d
Cleared Apr 25, 2024
Air Motor (Model name: FX204 M4)
K233308
Nakanishi, Inc.
Dental · 209d
Cleared Sep 22, 2023
High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors
K220179
Foshan Coxo Medical Instrument Co., Ltd.
Dental · 609d
Cleared Aug 23, 2023
EVO 700 series high speed handpiece
K232243
Ttbio Corp.
Dental · 26d
Cleared Jun 02, 2023
Titanium Turbine
K230888
Nakanishi, Inc.
Dental · 63d
Cleared Feb 22, 2023
TRAUS Air Dental Handpiece
K221741
Saeshin Precision Co., Ltd.
Dental · 252d
Cleared Dec 12, 2022
Medidenta High Speed Handpieces
K202674
Pac-Dent, Inc.
Dental · 818d
Cleared Nov 17, 2022
Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece
K212910
Shenzhen Carejoy Technology Co., Ltd.
Dental · 430d
Cleared Sep 28, 2022
Dental Air Polishing Handpiece
K221548
Guilin Woodpecker Medical Instrument Co., Ltd.
Dental · 124d
Cleared Jul 15, 2022
OK Handpiece
K221814
Jaintek Co.,Ltd
Dental · 23d
Cleared Jun 21, 2022
Stainless Turbine
K203791
Nakanishi, Inc.
Dental · 540d
Cleared Nov 08, 2021
Highspeed Airturbine Handpiece
K202371
Beijing Dongbo Dental Handpiece Co., Ltd.
Dental · 446d
Cleared Sep 03, 2021
Dental Low-speed Handpieces and Accessories
K202786
Microp Technology (Taiwan), Inc.
Dental · 346d
Cleared Aug 11, 2020
Disposable High Speed Air Turbine Handpiece
K193264
Ningbo Hpdove Dental Instruments Co., Ltd.
Dental · 259d
Cleared May 26, 2020
High-speed air turbine handpiece / Low-speed air turbine handpiece
K181691
Foshan Wenjian Medical Instrument Co., Ltd.
Dental · 699d
Cleared Mar 04, 2020
Lubrina 2
K190509
J. Morita USA, Inc.
Dental · 369d
Cleared Jan 13, 2020
Midwest Rhino XE and Air Motor M
K192409
Dentsply Sirona
Dental · 131d
Cleared Jan 06, 2020
SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece
K192412
Dentalez, Inc.
Dental · 124d

About Product Code EFB - Regulatory Context

510(k) Submission Activity

261 total 510(k) submissions under product code EFB since 1976, with 261 receiving FDA clearance (average review time: 166 days).

Submission volume has declined in recent years - 6 submissions in the last 24 months compared to 10 in the prior period.

FDA 510(k) Review Time - EFB Product Code

Recent submissions under EFB have taken an average of 216 days to reach a decision - up from 164 days historically. Manufacturers should account for longer review timelines in current project planning.

EFB devices are reviewed by the Dental panel. Browse all Dental devices →