Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
EBW · Predicate Candidate Screening
61 FDA 510(k) clearances under this product code; the 50 most recent screened below.
180 daysmedian FDA review time
382 days90th percentile
61clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251407 | Motor Handpiece and Control Unit (SDI10) | Saeshin Precision Co., Ltd. | 2026-01-30 | 269 | 0 |
| K251701 | Star E900 Electric System | Dentalez, Inc., Stardental Division | 2026-01-12 | 224 | 0 |
| K251811 | Motor and Apex Module (MaAM) | Dentsply Sirona, Inc. | 2025-08-25 | 74 | 0 |
| K231562 | ELEC ENGINE (Model: ISE-170L) | Micro-Nx Co., Ltd. | 2025-07-18 | 779 | 0 |
| K242646 | Dental Implant Unit | Guilin Aesthedent Medical Instruments Co., Ltd. | 2025-04-11 | 220 | 0 |
| K233288 | NLZ Built-In Motor System | Nakanishi, Inc. | 2024-06-24 | 269 | 0 |
| K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON- | Nakanishi, Inc. | 2024-06-20 | 267 | 0 |
| K230895 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MM | Cefla S.C. | 2024-04-01 | 367 | 0 |
| K231864 | Fiber Optic Brushless Electronic Micromotor, model: iM100 | Codent Technical Industry Co., Ltd. | 2024-03-11 | 259 | 0 |
| K211358 | Implanter incl. Accessories | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-11-21 | 567 | 0 |
| K220831 | Dental Implantation Systems, Dental Electrical Motors | Foshan Coxo Medical Instrument Co., Ltd. | 2022-09-27 | 189 | 0 |
| K213022 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR | Cefla S.C. | 2022-05-09 | 231 | 0 |
| K202075 | Dental Electric Motor | Foshan Cicada Dental Instrument Co, Ltd. | 2022-03-11 | 592 | 0 |
| K201191 | ELEC-LED | Micro-Nx Co., Ltd. | 2022-02-07 | 644 | 0 |
| K203706 | Dental Electric Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-01-13 | 391 | 0 |
| K201192 | Impla-NX (Model: ISE-270M) | Micro-Nx Co., Ltd. | 2021-05-21 | 382 | 0 |
| K201292 | TRAUS SIP20 | Saeshin Precision Co., Ltd. | 2021-02-11 | 273 | 0 |
| K193341 | iCTmotor (WL-1) | Dentium Co., Ltd. | 2020-09-04 | 276 | 0 |
| K180845 | Maxima Electric System | Handpiece Headquarters - Hpr, Inc. | 2019-07-25 | 479 | 0 |
| K181858 | Electric Handpiece Motor | W&H Dentalwerk Buermoos GmbH | 2019-03-26 | 257 | 0 |
| K173905 | Surgic Pro, Surgic Pro+ | Nakanishi, Inc. | 2018-06-19 | 179 | 0 |
| K163402 | NLZ Motor System | Nakanishi, Inc. | 2017-08-31 | 269 | 0 |
| K163131 | A-dec NLZ Electric Motor System | Nakanishi, Inc. | 2017-05-11 | 184 | 0 |
| K163317 | ELECTROmatic | Kaltenbach & Voigt Gmgh | 2017-02-21 | 90 | 0 |
| K161213 | XSmart iQ | Dentsply Sirona | 2017-02-10 | 287 | 0 |
| K161957 | W&H Implantmed SI-1015 incl. Accessories | W&H Dentalwerk Burmoos GmbH | 2016-11-23 | 128 | 0 |
| K141482 | KI-20 | Saeyang Microtech Co., Ltd. | 2015-04-24 | 324 | 0 |
| K140308 | MASTERSURG / EXPERTSURG | Kaltenbach & Voigt GmbH | 2014-08-15 | 189 | 0 |
| K133776 | A-DEC/W&H ELECTRIC HANDPIECE MOTOR | A-Dec, Inc. | 2014-05-28 | 167 | 0 |
| K132570 | ELECTRIC HANDPIECE SYSTEM | Ttbio Corp. | 2014-04-29 | 257 | 0 |
| K123608 | ENDO E CLASS | Saeyang Microtech Co., Ltd. | 2013-08-16 | 268 | 0 |
| K111623 | I-ENDO DUAL | Satelec - Acteon Group | 2012-01-10 | 214 | 0 |
| K103027 | ELECTROTORQUE TLC | Kaltenbach & Voigt GmbH | 2011-08-19 | 310 | 0 |
| K103653 | E3 TORQUE CONTROL MOTOR | Dentsply International, Inc. | 2011-05-26 | 164 | 0 |
| K102241 | ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UN | Anthogyr Sas | 2011-03-23 | 226 | 0 |
| K100785 | BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES | Bonart Co., Ltd. | 2010-12-03 | 259 | 0 |
| K092214 | CHIROPRO L SYSTEM | Bien-Air Dental, SA | 2009-12-15 | 146 | 1 |
| K092758 | X-CUBE | Saeshin Precision Co., Ltd. | 2009-09-21 | 12 | 0 |
| K090727 | IMM DENTAL IRRIGATION TUBING SET | Innovative Medical Manufacturing Co. | 2009-08-13 | 147 | 0 |
| K090937 | E-STATIS 40 SYSTEM | Scican , Ltd. | 2009-07-24 | 112 | 0 |
| K083252 | NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM | Dentalez Group, Stardental Division | 2009-02-18 | 106 | 0 |
| K060287 | DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM | W&H Dentalwerk Buermoos GmbH | 2006-05-03 | 86 | 0 |
| K052741 | IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VE | W&H Dentalwerk Buermoos GmbH | 2006-01-13 | 105 | 0 |
| K041124 | IRRIGATION TUBING SET 2.2M AND 3.8M | W&H Dentalwerk Burmoos | 2004-06-07 | 39 | 0 |
| K040153 | I-TEC PORTABLE DENTAL OPERATORY | Indigenous Peoples Technology and Education Center | 2004-05-21 | 119 | 0 |
| K032572 | A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT | A-Dec, Inc. | 2003-12-03 | 105 | 0 |
| K031584 | SIROTORQUE L | Sirona Dental Systems GmbH | 2003-08-19 | 90 | 0 |
| K014068 | ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-2 | W&H Dentalwerk Buermoos GmbH | 2002-05-03 | 144 | 0 |
| K020327 | SURGIC IV IMPLANT CONTROL UNIT | Nakanishi, Inc. | 2002-04-08 | 67 | 0 |
| K011926 | ELEC-MATE E | Nakanishi, Inc. | 2001-09-11 | 83 | 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