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Panels › Dental › Product code EFB · Class 1

Handpiece, Air-Powered, Dental

Regulation 872.4200

4510(k)s in 12 months (263 all time)
0recalls in 12 months (8 all time)
7recalls that name a 510(k)
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Top companies in EFB

Company510(k)sRecalls
A-Dec, Inc.190
Nakanishi, Inc.101
Dentsply Intl.80
Micro Motors, Inc.70
Dentalez, Inc.60
E.M.S Electro Medical Systems S.A60
J. Morita USA, Inc.50
Midwest50
Mti Precision Products41
Nsk Nakanishi, Inc.50
Decided510(k)Device and applicantCode
Oct 1, 2026K260029Firstar Dental Handpieces
FDC Technology Industry Co.
EFB
Sep 23, 2026K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece
SETAGAYA SEIKI Co., Ltd., JP
EFB
Jan 12, 2026K251389High speed air turbine handpiece
Foshan Topmed Dental Co., Ltd., CN
EFB
Jan 12, 2026K251388Dental 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
Foshan Topmed Dental Co., Ltd., CN
EFB
Feb 28, 2025K242179Synea Fusion Handpieces (Intensiv & Profin)
W&H Dentalwerk Bürmoos GmbH, AT
EFB
Nov 13, 2024K240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
Guangdong Jinme Medical Technology Co., Ltd., CN
EFB
Nov 12, 2024K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straig
Foshan Soco Precision Instrument Co., Ltd., CN
EFB
Sep 20, 2024K241880Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)
Nakanishi, Inc., JP
EFB
Apr 30, 2024K233122High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)
Litu Tech , Ltd., CN
EFB
Apr 25, 2024K233308Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)
Nakanishi, Inc., JP
EFB
Sep 22, 2023K220179High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors
Foshan Coxo Medical Instrument Co., Ltd., CN
EFB
Aug 23, 2023K232243EVO 700 series high speed handpiece
Ttbio Corp., CN
EFB
Jun 2, 2023K230888Titanium Turbine
Nakanishi, Inc., JP
EFB
Feb 22, 2023K221741TRAUS Air Dental Handpiece
Saeshin Precision Co., Ltd., KR
EFB
Dec 12, 2022K202674Medidenta High Speed Handpieces
Pac-Dent, Inc.
EFB
Nov 17, 2022K212910Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece
Shenzhen Carejoy Technology Co., Ltd., CN
EFB
Sep 28, 2022K221548Dental Air Polishing Handpiece
Guilin Woodpecker Medical Instrument Co., Ltd., CN
EFB
Jul 15, 2022K221814OK Handpiece
Jaintek Co.,Ltd, KR
EFB
Jun 21, 2022K203791Stainless Turbine
Nakanishi, Inc., JP
EFB
Nov 8, 2021K202371Highspeed Airturbine Handpiece
Beijing Dongbo Dental Handpiece Co., Ltd., CN
EFB
Sep 3, 2021K202786Dental Low-speed Handpieces and Accessories
Microp Technology (Taiwan), Inc., TW
EFB
Aug 11, 2020K193264Disposable High Speed Air Turbine Handpiece
Ningbo Hpdove Dental Instruments Co., Ltd., CN
EFB
May 26, 2020K181691High-speed air turbine handpiece / Low-speed air turbine handpiece
Foshan Wenjian Medical Instrument Co., Ltd., CN
EFB
Mar 4, 2020K190509Lubrina 2
J. Morita USA, Inc.
EFB
Jan 13, 2020K192409Midwest Rhino XE and Air Motor M
Dentsply Sirona
EFB
Jan 6, 2020K192412SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Ha
Dentalez, Inc.
EFB
Dec 11, 2019K190508EVO 450 series High Speed Handpieces
Ttbio Corp., TW
EFB
Dec 9, 2019K181900Dental high speed handpiece, Dental low speed handpiece
Foshan Cicada Dental Instrument Co, Ltd., CN
EFB
Apr 10, 2019K181110PROPHYflex 4
Kaltenbach & Voigt GmbH, DE
EFB
Jul 24, 2018K173943Dental High-speed Handpiece and Accessories
Microp Technology (Taiwan), Inc., TW
EFB
Jul 11, 2018K172543High-speed Turbine Handpieces for Single Use
Beijing Dongbo Dental Handpiece Co., Ltd., CN
EFB
Mar 28, 2018K173465Concentrix MX-AC High-Speed Handpiece
Dentalez, Inc.
EFB
Dec 18, 2017K171174PERIO-FLOW nozzle
E.M.S Electro Medical Systems S.A, CH
EFB
Dec 8, 2017K171553W&H Assistina Twin
W&H Dentalwerk Buermoos GmbH, AT
EFB
Nov 21, 2017K170236Dental Low-speed Turbine Handpiece
Guangdong Jinme Medical Technology Co., Ltd., CN
EFB
Nov 8, 2017K170229Dental High-speed Turbine Handpiece
Guangdong Jinme Medical Technology Co., Ltd., CN
EFB
Oct 19, 2017K170261Premium Plus Prophy Air Motor
Premium Plus International Limited, CN
EFB
Aug 15, 2017K163483PANA SPRAY Plus
Nakanishi, Inc., JP
EFB
Feb 23, 2017K162926Air-Powered Handpieces and Handpiece Attachments
W&H Dentalwerk Burmoos GmbH, AT
EFB
Sep 29, 2016K160410WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head
Dental Savings Club, CA
EFB
Apr 8, 2016K153411430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece
Dentalez, Inc.
EFB
Feb 3, 2016K151912AIR-FLOW handy 3.0 PLUS
E.M.S Electro Medical Systems S.A, CH
EFB
Dec 8, 2015K152146High Speed Handpieces and Accessories
Codent Technical Industry Co., Ltd., TW
EFB
Nov 23, 2015K143704Advanced Air System
W&H Dentalwerk Buermoos GmbH, AT
EFB
May 13, 2015K141886MDK HANDPIECES
Modern Korea Co., Ltd.
EFB
May 4, 2015K141576Maxima PRO 45L
Kavo DO Brasil Industria E Comercio Ltda, BR
EFB
Apr 24, 2015K150798Codent Low Speed Dental Handpieces and Accessories
Codent Technical Industry Co., Ltd., TW
EFB
Feb 27, 2015K141183EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES
Ttbio Corp., TW
EFB
Feb 17, 2015K143183Maxima XTEND Handpiece Maintenance System
Handpiece Headquarters
EFB
Oct 28, 2014K142063#8C RENEGADE DENTAL HANDPIECE
Handpiece Club, LLC
EFB

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