FDA Product Code
FDA Product Code EKX — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.4200
510(k) Clearances — 90 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261987 | Reusable SmartPeg | Osstell AB | 2026-09-08 | Traditional | PDF ↗ |
| K252223 | Alpha Endo Handpiece (Alpha Endo) | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | 2025-10-16 | Traditional | PDF ↗ |
| K251597 | InnerView System | Perimetrics, Inc. | 2025-09-18 | Traditional | PDF ↗ |
| K243692 | EnDrive (EnDriveUS) | Advanced Technology Research (A.T.R.) S.R.L. | 2025-08-22 | Traditional | PDF ↗ |
| K242514 | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | Shenzhen Rogin Medical Co., Ltd. | 2025-04-24 | Traditional | PDF ↗ |
| K241065 | ChecQ (AC100) | Dentis Co., Ltd. | 2025-03-21 | Traditional | PDF ↗ |
| K243911 | HPR Cordless Hygiene Handpiece | Handpiece Headquarters | 2024-12-20 | Traditional | PDF ↗ |
| K222688 | The Trust | Genoss Co., Ltd. | 2024-08-09 | Traditional | PDF ↗ |
| K233865 | X-Smart Pro; X-Smart Pro+ | Dentsply Sirona, Inc. | 2024-07-24 | Traditional | PDF ↗ |
| K232551 | EM-07 Cordless Endo Motor | Forum Engineering Technologies (96) , Ltd. | 2024-07-09 | Traditional | PDF ↗ |
| K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | Micro-Nx Co., Ltd. | 2023-11-09 | Traditional | PDF ↗ |
| K232657 | InnerView LC | Perimetrics, Inc. | 2023-09-01 | Traditional | PDF ↗ |
| K220829 | Endo Motor | Foshan Coxo Medical Instrument Co., Ltd. | 2023-05-18 | Traditional | PDF ↗ |
| K222548 | Endo Motor | Shenzhen Perfect Medical Instruments Co., Ltd. | 2023-04-26 | Traditional | PDF ↗ |
| K210475 | EQ-M | Meta Systems Co., Ltd. | 2022-09-21 | Traditional | PDF ↗ |
| K213897 | Pro M Class | Saeyang Microtech Co., Ltd. | 2022-09-19 | Traditional | PDF ↗ |
| K212043 | TRAUS ENDO | Saeshin Precision Co., Ltd. | 2022-06-24 | Special | PDF ↗ |
| K211531 | Cordless Prophy System, Model: i-Polish | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021-12-17 | Traditional | PDF ↗ |
| K203320 | Endo Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021-05-10 | Traditional | PDF ↗ |
| K192649 | Endo Motor | Foshan Cicada Dental Instrument Co, Ltd. | 2021-03-12 | Traditional | PDF ↗ |
| K201703 | PROXEO Twist Cordless Polishing System PL-40 H | W&H Dentalwerk Buermoos GmbH | 2021-02-24 | Traditional | PDF ↗ |
| K201993 | E-connect S Endo Motor with built-in Apex Locator | Changzhou Sifary Medical Technology Co., Ltd. | 2021-01-29 | Traditional | PDF ↗ |
| K191276 | Dental Electrical Motor iRoot Pro | Changzhou Bomedent Medical Technology Co.,Ltd | 2020-06-30 | Traditional | PDF ↗ |
| K181888 | Osstell Beacon | Osstell AB | 2019-08-22 | Traditional | PDF ↗ |
| K180682 | AeroPro Cordless Prophy System | Premier Dental Company Products | 2019-02-27 | Traditional | PDF ↗ |
| K180953 | AnyCheck IMT-100 | Dms Co., Ltd. | 2019-02-20 | Traditional | PDF ↗ |
| K173920 | LS OIL | J. Morita USA, Inc. | 2018-10-11 | Traditional | PDF ↗ |
| K171377 | Young INFINITY Cordless Handpiece System | Young Dental Manufacturing Co. 1, LLC | 2018-08-20 | Traditional | PDF ↗ |
| K180527 | IS3 | Hiossen, Inc. | 2018-05-16 | Traditional | PDF ↗ |
| K170275 | Tri Auto ZX2 | J. Morita USA, Inc. | 2017-09-11 | Traditional | PDF ↗ |
| K161500 | MEG-TORQ | Micro-Nx Co., Ltd. | 2017-02-22 | Traditional | PDF ↗ |
| K160825 | MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology | Dentsply Sirona | 2016-09-27 | Traditional | PDF ↗ |
| K153285 | EMS-200 | Meta Systems Co., Ltd. | 2016-08-12 | Traditional | PDF ↗ |
| K143445 | Tellos ISQ Buddy | Tellos Medical AB | 2016-01-07 | Traditional | PDF ↗ |
| K143411 | TRAUS ENDO | Saeshin Precision Co., Ltd. | 2015-06-29 | Traditional | PDF ↗ |
| K150129 | AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) | Aseptico, Inc. | 2015-05-28 | Traditional | PDF ↗ |
| K142358 | Osstell IDx | Osstell AB | 2015-02-19 | Traditional | PDF ↗ |
| K142124 | AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM | Aseptico, Inc. | 2014-12-31 | Traditional | PDF ↗ |
| K133298 | ENDO SMART | Meta Biomed, Inc. | 2014-09-19 | Traditional | PDF ↗ |
| K132401 | MEGA ISQ | Osstell AB | 2014-04-09 | Special | PDF ↗ |
| K131578 | IPROPHY MOBILE | Nakanishi, Inc. | 2013-09-12 | Traditional | PDF ↗ |
| K123582 | ENDO A CLASS | Saeyang Microtech Co., Ltd. | 2013-08-16 | Traditional | PDF ↗ |
| K112665 | TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE | J. Morita USA, Inc. | 2012-05-04 | Traditional | PDF ↗ |
| K110278 | CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 | Nakanishi, Inc. | 2012-02-15 | Traditional | PDF ↗ |
| K111616 | E-CUBE | Saeshin Precision Co., Ltd. | 2011-08-19 | Traditional | PDF ↗ |
| K111078 | AEU-26L ELCTRONIC ENDODONTIC SYSTEM | Aseptico, Inc. | 2011-06-14 | Abbreviated | PDF ↗ |
| K110753 | MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM | Dentsply International, Inc. | 2011-06-06 | Traditional | PDF ↗ |
| K103399 | GENERAL DENISTRY MOTOR | Aseptico, Inc. | 2011-02-28 | Traditional | PDF ↗ |
| K100600 | PROSTHODONTIC SCREWDRIVER , MODEL IA-400 | W&H Dentalwerk Buermoos GmbH | 2010-07-09 | Traditional | PDF ↗ |
| K101612 | ZEN CORDLESS PROPHY SYSTEM | Discus Dental, LLC | 2010-06-30 | Traditional | PDF ↗ |
| K092833 | ENDOMAX CORDLESS ENDODONTIC HANDPIECE | Dentamerica | 2010-01-07 | Traditional | PDF ↗ |
| K090931 | CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR | W&H Dentalwerk Buermoos GmbH | 2009-12-15 | Abbreviated | PDF ↗ |
| K092614 | X-SMART EASY | Dentsply Interntional | 2009-12-02 | Traditional | PDF ↗ |
| K091913 | HI TECH IMPLANT, HT PHYSIO IMPLANT | By Dental Srl | 2009-10-30 | Traditional | PDF ↗ |
| K082325 | APEXUM ABLATOR | Apexum , Ltd. | 2009-04-21 | Traditional | PDF ↗ |
| K082523 | OSSTELL ISQ IMPLANT STABILITY METER | Osstell AB | 2008-09-26 | Special | PDF ↗ |
| K072213 | PERIMETRICS PERIOMETER | Perimetrics, Inc. | 2008-08-29 | Traditional | PDF ↗ |
| K081191 | TCM ENDO 20 | NOUVAG AG | 2008-08-07 | Traditional | PDF ↗ |
| K071190 | ROOT ZX II | J. Morita USA, Inc. | 2007-08-17 | Traditional | PDF ↗ |
| K063007 | POWERTOME PERIOTOME | Westport Medical, Inc. | 2006-10-17 | Traditional | PDF ↗ |
| K052515 | SIROENDO | Sirona Dental Systems GmbH | 2006-03-31 | Traditional | PDF ↗ |
| K051661 | IMPLANT HANDPIECES | Sirona Dental Systems GmbH | 2005-09-06 | Traditional | PDF ↗ |
| K050612 | LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE | Lightspeed Technology, Inc. | 2005-05-04 | Traditional | PDF ↗ |
| K042822 | TCM ENDO V, MODEL 1534 | NOUVAG AG | 2004-12-22 | Traditional | PDF ↗ |
| K041279 | IMPLANTEO IMPLANTOLOGY MOTOR | Anthogyr | 2004-09-23 | Abbreviated | PDF ↗ |
| K033689 | OSSTELL MENTOR RFA | Integration Diagnostics, Ltd. | 2004-02-26 | Traditional | PDF ↗ |
| K033597 | ATR 5000, LC 5000, IMPLANT SYSTEM | Advanced Technology Research (A.T.R.) S.R.L. | 2003-11-25 | Traditional | PDF ↗ |
| K031204 | DENTAPORT ZX | J. Morita USA, Inc. | 2003-08-21 | Traditional | PDF ↗ |
| K031540 | APEX ELECTRIC HANDPIECE SYSTEM | Lares Research, Inc. | 2003-06-30 | Traditional | PDF ↗ |
| K030163 | ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 | Aseptico, Inc. | 2003-03-03 | Traditional | PDF ↗ |
| K012944 | POWER DRIVE | Mediteam AB | 2001-11-20 | Traditional | PDF ↗ |
| K003714 | OSSTELL RESONANCE FREQUENCY ANALYZER | Integration Diagnostics, Ltd. | 2001-08-09 | Traditional | PDF ↗ |
| K993188 | ENDOSTEPPER 1 | Phytron- Elektronik GmbH | 1999-09-28 | Traditional | PDF ↗ |
| K990739 | QUANTEC-E ENDO SYSTEM | Sybron Dental Specialties, Inc. | 1999-05-26 | Traditional | PDF ↗ |
| K990682 | PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) | Nsk Nakanishi, Inc. | 1999-03-24 | Traditional | PDF ↗ |
| K990646 | PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE | Nsk Nakanishi, Inc. | 1999-03-19 | Traditional | PDF ↗ |
| K983413 | MODEL MS-1 HANDPIECE | Parkell, Inc. | 1998-12-21 | Traditional | PDF ↗ |
| K970339 | TRI AUTO ZX | J. Morita USA, Inc. | 1997-06-04 | Traditional | PDF ↗ |
| K932600 | MODIFIED SITE POWER HANDPIECE II | Chiron Vision Corp. | 1994-01-25 | Traditional | PDF ↗ |
| K915634 | FRESENIUS PD+ EXCHANGE DEVICE | Fresenius USA, Inc. | 1993-07-01 | Traditional | PDF ↗ |
| K922077 | MODIFIED SITE POWER HANDPIECE | Chiron Vision Corp. | 1992-06-23 | Traditional | PDF ↗ |
| K905071 | MX CYCLER | Dakmed, Inc. | 1991-05-28 | Traditional | PDF ↗ |
| K872171 | PERIOTEST | Siemens Medical Solutions USA, Inc. | 1987-06-23 | Traditional | PDF ↗ |
| K870797 | PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE | Safco Dental Supply | 1987-05-01 | Traditional | PDF ↗ |
| K832063 | ROBIN CORDLESS HANDPIECE | Kaycor Intl., Ltd. | 1983-08-26 | Traditional | PDF ↗ |
| K821739 | J. MORITA FLEX M-3 TORX HARDPIECE | Pacific Dental Corp. | 1982-06-25 | Traditional | PDF ↗ |
| K813348 | YOSHIDA RIDO-F, MODEL LM-01 | Kaycor Intl., Ltd. | 1982-01-07 | Traditional | PDF ↗ |
| K801687 | TORX MICRO-MOTOR LOW SPEED HANDPIECE | Pacific Dental Corp. | 1980-08-04 | Traditional | PDF ↗ |
| K780646 | AIR-PWOERED COLDRILL | Medishield, Inc. | 1978-04-28 | Traditional | PDF ↗ |
| K760724 | PERITONEAL DIALYSIS SYSTEM | Physio-Control Corp. | 1976-11-23 | Traditional | PDF ↗ |
Product code EKX · Class I · Dental. Data: openFDA.