Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
EKX — Predicate Candidate Screening
89 FDA 510(k) clearances under this product code; the 50 most recent screened below.
128 daysmedian FDA review time
401 days90th percentile
89clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252223 | Alpha Endo Handpiece (Alpha Endo) | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | 2025-10-16 | 92 | 0 |
| K251597 | InnerView System | Perimetrics, Inc. | 2025-09-18 | 114 | 0 |
| K243692 | EnDrive (EnDriveUS) | Advanced Technology Research (A.T.R.) S.R.L. | 2025-08-22 | 266 | 0 |
| K242514 | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | Shenzhen Rogin Medical Co., Ltd. | 2025-04-24 | 244 | 0 |
| K241065 | ChecQ (AC100) | Dentis Co., Ltd. | 2025-03-21 | 337 | 0 |
| K243911 | HPR Cordless Hygiene Handpiece | Handpiece Headquarters | 2024-12-20 | 1 | 0 |
| K222688 | The Trust | Genoss Co., Ltd. | 2024-08-09 | 703 | 0 |
| K233865 | X-Smart Pro; X-Smart Pro+ | Dentsply Sirona, Inc. | 2024-07-24 | 231 | 0 |
| K232551 | EM-07 Cordless Endo Motor | Forum Engineering Technologies (96) , Ltd. | 2024-07-09 | 321 | 0 |
| K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | Micro-Nx Co., Ltd. | 2023-11-09 | 58 | 0 |
| K232657 | InnerView LC | Perimetrics, Inc. | 2023-09-01 | 1 | 0 |
| K220829 | Endo Motor | Foshan Coxo Medical Instrument Co., Ltd. | 2023-05-18 | 422 | 0 |
| K222548 | Endo Motor | Shenzhen Perfect Medical Instruments Co., Ltd. | 2023-04-26 | 246 | 0 |
| K210475 | EQ-M | Meta Systems Co., Ltd. | 2022-09-21 | 581 | 0 |
| K213897 | Pro M Class | Saeyang Microtech Co., Ltd. | 2022-09-19 | 279 | 0 |
| K212043 | TRAUS ENDO | Saeshin Precision Co., Ltd. | 2022-06-24 | 359 | 0 |
| K211531 | Cordless Prophy System, Model: i-Polish | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021-12-17 | 214 | 0 |
| K203320 | Endo Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021-05-10 | 179 | 0 |
| K192649 | Endo Motor | Foshan Cicada Dental Instrument Co, Ltd. | 2021-03-12 | 535 | 0 |
| K201703 | PROXEO Twist Cordless Polishing System PL-40 H | W&H Dentalwerk Buermoos GmbH | 2021-02-24 | 247 | 0 |
| K201993 | E-connect S Endo Motor with built-in Apex Locator | Changzhou Sifary Medical Technology Co., Ltd. | 2021-01-29 | 196 | 0 |
| K191276 | Dental Electrical Motor iRoot Pro | Changzhou Bomedent Medical Technology Co.,Ltd | 2020-06-30 | 414 | 0 |
| K181888 | Osstell Beacon | Osstell AB | 2019-08-22 | 405 | 0 |
| K180682 | AeroPro Cordless Prophy System | Premier Dental Company Products | 2019-02-27 | 349 | 0 |
| K180953 | AnyCheck IMT-100 | Dms Co., Ltd. | 2019-02-20 | 315 | 0 |
| K173920 | LS OIL | J. Morita USA, Inc. | 2018-10-11 | 293 | 0 |
| K171377 | Young INFINITY Cordless Handpiece System | Young Dental Manufacturing Co. 1, LLC | 2018-08-20 | 467 | 0 |
| K180527 | IS3 | Hiossen, Inc. | 2018-05-16 | 77 | 0 |
| K170275 | Tri Auto ZX2 | J. Morita USA, Inc. | 2017-09-11 | 224 | 0 |
| K161500 | MEG-TORQ | Micro-Nx Co., Ltd. | 2017-02-22 | 266 | 0 |
| K160825 | MIDWEST RDH Freedom Cordless Prophy System with SmartMode Te | Dentsply Sirona | 2016-09-27 | 186 | 0 |
| K153285 | EMS-200 | Meta Systems Co., Ltd. | 2016-08-12 | 274 | 0 |
| K143445 | Tellos ISQ Buddy | Tellos Medical AB | 2016-01-07 | 401 | 0 |
| K143411 | TRAUS ENDO | Saeshin Precision Co., Ltd. | 2015-06-29 | 213 | 0 |
| K150129 | AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERS | Aseptico, Inc. | 2015-05-28 | 127 | 0 |
| K142358 | Osstell IDx | Osstell AB | 2015-02-19 | 178 | 0 |
| K142124 | AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM | Aseptico, Inc. | 2014-12-31 | 149 | 0 |
| K133298 | ENDO SMART | Meta Biomed, Inc. | 2014-09-19 | 329 | 0 |
| K132401 | MEGA ISQ | Osstell AB | 2014-04-09 | 251 | 0 |
| K131578 | IPROPHY MOBILE | Nakanishi, Inc. | 2013-09-12 | 104 | 0 |
| K123582 | ENDO A CLASS | Saeyang Microtech Co., Ltd. | 2013-08-16 | 269 | 0 |
| K112665 | TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE | J. Morita USA, Inc. | 2012-05-04 | 234 | 0 |
| K110278 | CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION S | Nakanishi, Inc. | 2012-02-15 | 380 | 0 |
| K111616 | E-CUBE | Saeshin Precision Co., Ltd. | 2011-08-19 | 70 | 0 |
| K111078 | AEU-26L ELCTRONIC ENDODONTIC SYSTEM | Aseptico, Inc. | 2011-06-14 | 57 | 0 |
| K110753 | MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM | Dentsply International, Inc. | 2011-06-06 | 80 | 0 |
| K103399 | GENERAL DENISTRY MOTOR | Aseptico, Inc. | 2011-02-28 | 101 | 0 |
| K100600 | PROSTHODONTIC SCREWDRIVER , MODEL IA-400 | W&H Dentalwerk Buermoos GmbH | 2010-07-09 | 128 | 0 |
| K101612 | ZEN CORDLESS PROPHY SYSTEM | Discus Dental, LLC | 2010-06-30 | 21 | 0 |
| K092833 | ENDOMAX CORDLESS ENDODONTIC HANDPIECE | Dentamerica | 2010-01-07 | 114 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda