Atlas FDA

EKX

89 FDA 510(k) clearances · Product code

128 daysmedian time to decision
401 days90th percentile
89clearances measured

FDA profile

Official device name
Handpiece, Direct Drive, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2019: 56 · 2020: 67 · 2021: 79 · 2022: 37 · 2024: 19 · 2026: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Alpha Endo Handpiece (Alpha Endo) (K252223)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.2025-10-16
InnerView System (K251597)Perimetrics, Inc.2025-09-18
EnDrive (EnDriveUS) (K243692)Advanced Technology Research (A.T.R.) S.R.L.2025-08-22
Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) (K242514)Shenzhen Rogin Medical Co., Ltd.2025-04-24
ChecQ (AC100) (K241065)Dentis Co., Ltd.2025-03-21
HPR Cordless Hygiene Handpiece (K243911)Handpiece Headquarters2024-12-20
The Trust (K222688)Genoss Co., Ltd.2024-08-09
X-Smart Pro; X-Smart Pro+ (K233865)Dentsply Sirona, Inc.2024-07-24
EM-07 Cordless Endo Motor (K232551)Forum Engineering Technologies (96) , Ltd.2024-07-09
Dental Handpiece, Wireless Endodontic Handpiece, endoit (K232810)Micro-Nx Co., Ltd.2023-11-09
InnerView LC (K232657)Perimetrics, Inc.2023-09-01
Endo Motor (K220829)Foshan Coxo Medical Instrument Co., Ltd.2023-05-18
Endo Motor (K222548)Shenzhen Perfect Medical Instruments Co., Ltd.2023-04-26
EQ-M (K210475)Meta Systems Co., Ltd.2022-09-21
Pro M Class (K213897)Saeyang Microtech Co., Ltd.2022-09-19
TRAUS ENDO (K212043)Saeshin Precision Co., Ltd.2022-06-24
Cordless Prophy System, Model: i-Polish (K211531)Guilin Woodpecker Medical Instrument Co., Ltd.2021-12-17
Endo Motor (K203320)Guilin Woodpecker Medical Instrument Co., Ltd.2021-05-10
Endo Motor (K192649)Foshan Cicada Dental Instrument Co, Ltd.2021-03-12
PROXEO Twist Cordless Polishing System PL-40 H (K201703)W&H Dentalwerk Buermoos GmbH2021-02-24
E-connect S Endo Motor with built-in Apex Locator (K201993)Changzhou Sifary Medical Technology Co., Ltd.2021-01-29
Dental Electrical Motor iRoot Pro (K191276)Changzhou Bomedent Medical Technology Co.,Ltd2020-06-30
Osstell Beacon (K181888)Osstell AB2019-08-22
AeroPro Cordless Prophy System (K180682)Premier Dental Company Products2019-02-27
AnyCheck IMT-100 (K180953)Dms Co., Ltd.2019-02-20
LS OIL (K173920)J. Morita USA, Inc.2018-10-11
Young INFINITY Cordless Handpiece System (K171377)Young Dental Manufacturing Co. 1, LLC2018-08-20
IS3 (K180527)Hiossen, Inc.2018-05-16
Tri Auto ZX2 (K170275)J. Morita USA, Inc.2017-09-11
MEG-TORQ (K161500)Micro-Nx Co., Ltd.2017-02-22
MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology (K160825)Dentsply Sirona2016-09-27
EMS-200 (K153285)Meta Systems Co., Ltd.2016-08-12
Tellos ISQ Buddy (K143445)Tellos Medical AB2016-01-07
TRAUS ENDO (K143411)Saeshin Precision Co., Ltd.2015-06-29
AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) (K150129)Aseptico, Inc.2015-05-28
Osstell IDx (K142358)Osstell AB2015-02-19
AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM (K142124)Aseptico, Inc.2014-12-31
ENDO SMART (K133298)Meta Biomed, Inc.2014-09-19
MEGA ISQ (K132401)Osstell AB2014-04-09
IPROPHY MOBILE (K131578)Nakanishi, Inc.2013-09-12
ENDO A CLASS (K123582)Saeyang Microtech Co., Ltd.2013-08-16
TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE (K112665)J. Morita USA, Inc.2012-05-04
CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 (K110278)Nakanishi, Inc.2012-02-15
E-CUBE (K111616)Saeshin Precision Co., Ltd.2011-08-19
AEU-26L ELCTRONIC ENDODONTIC SYSTEM (K111078)Aseptico, Inc.2011-06-14
MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM (K110753)Dentsply International, Inc.2011-06-06
GENERAL DENISTRY MOTOR (K103399)Aseptico, Inc.2011-02-28
PROSTHODONTIC SCREWDRIVER , MODEL IA-400 (K100600)W&H Dentalwerk Buermoos GmbH2010-07-09
ZEN CORDLESS PROPHY SYSTEM (K101612)Discus Dental, LLC2010-06-30
ENDOMAX CORDLESS ENDODONTIC HANDPIECE (K092833)Dentamerica2010-01-07
CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR (K090931)W&H Dentalwerk Buermoos GmbH2009-12-15
X-SMART EASY (K092614)Dentsply Interntional2009-12-02
HI TECH IMPLANT, HT PHYSIO IMPLANT (K091913)By Dental Srl2009-10-30
APEXUM ABLATOR (K082325)Apexum , Ltd.2009-04-21
OSSTELL ISQ IMPLANT STABILITY METER (K082523)Osstell AB2008-09-26
PERIMETRICS PERIOMETER (K072213)Perimetrics, Inc.2008-08-29
TCM ENDO 20 (K081191)NOUVAG AG2008-08-07
ROOT ZX II (K071190)J. Morita USA, Inc.2007-08-17
POWERTOME PERIOTOME (K063007)Westport Medical, Inc.2006-10-17
SIROENDO (K052515)Sirona Dental Systems GmbH2006-03-31
IMPLANT HANDPIECES (K051661)Sirona Dental Systems GmbH2005-09-06
LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE (K050612)Lightspeed Technology, Inc.2005-05-04
TCM ENDO V, MODEL 1534 (K042822)NOUVAG AG2004-12-22
IMPLANTEO IMPLANTOLOGY MOTOR (K041279)Anthogyr2004-09-23
OSSTELL MENTOR RFA (K033689)Integration Diagnostics, Ltd.2004-02-26
ATR 5000, LC 5000, IMPLANT SYSTEM (K033597)Advanced Technology Research (A.T.R.) S.R.L.2003-11-25
DENTAPORT ZX (K031204)J. Morita USA, Inc.2003-08-21
APEX ELECTRIC HANDPIECE SYSTEM (K031540)Lares Research, Inc.2003-06-30
ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 (K030163)Aseptico, Inc.2003-03-03
POWER DRIVE (K012944)Mediteam AB2001-11-20
OSSTELL RESONANCE FREQUENCY ANALYZER (K003714)Integration Diagnostics, Ltd.2001-08-09
ENDOSTEPPER 1 (K993188)Phytron- Elektronik GmbH1999-09-28
QUANTEC-E ENDO SYSTEM (K990739)Sybron Dental Specialties, Inc.1999-05-26
PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) (K990682)Nsk Nakanishi, Inc.1999-03-24
PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE (K990646)Nsk Nakanishi, Inc.1999-03-19
MODEL MS-1 HANDPIECE (K983413)Parkell, Inc.1998-12-21
TRI AUTO ZX (K970339)J. Morita USA, Inc.1997-06-04
MODIFIED SITE POWER HANDPIECE II (K932600)Chiron Vision Corp.1994-01-25
FRESENIUS PD+ EXCHANGE DEVICE (K915634)Fresenius USA, Inc.1993-07-01
MODIFIED SITE POWER HANDPIECE (K922077)Chiron Vision Corp.1992-06-23
MX CYCLER (K905071)Dakmed, Inc.1991-05-28
PERIOTEST (K872171)Siemens Medical Solutions USA, Inc.1987-06-23
PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE (K870797)Safco Dental Supply1987-05-01
ROBIN CORDLESS HANDPIECE (K832063)Kaycor Intl., Ltd.1983-08-26
J. MORITA FLEX M-3 TORX HARDPIECE (K821739)Pacific Dental Corp.1982-06-25
YOSHIDA RIDO-F, MODEL LM-01 (K813348)Kaycor Intl., Ltd.1982-01-07
TORX MICRO-MOTOR LOW SPEED HANDPIECE (K801687)Pacific Dental Corp.1980-08-04
AIR-PWOERED COLDRILL (K780646)Medishield, Inc.1978-04-28
PERITONEAL DIALYSIS SYSTEM (K760724)Physio-Control Corp.1976-11-23

Track EKX automatically

Every clearance here is in the API, with alerts when new ones post.