Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
LQY — Predicate Candidate Screening
46 FDA 510(k) clearances under this product code; the 50 most recent screened below.
158 daysmedian FDA review time
281 days90th percentile
46clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252224 | Apex Locator (FindPex) | Changzhou Sifary Medical Technology Co., Ltd. | 2026-04-08 | 266 | 0 |
| K242383 | Apex Locator | Shenzhen Rogin Medical Co., Ltd. | 2025-03-07 | 207 | 0 |
| K242765 | Electronic Apex Locator (Alpha Apex I) | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | 2025-01-17 | 126 | 0 |
| K231990 | Apex Locator | Cefla S.C. | 2024-02-13 | 223 | 0 |
| K232717 | Apex Locator (AL-Pex), Apex Locator (AL-Pex+) | Changzhou Haili Medical Co., Ltd. | 2023-12-22 | 108 | 0 |
| K212178 | Root Apex Locator | Foshan Coxo Medical Instrument Co., Ltd. | 2022-07-20 | 373 | 0 |
| K210789 | EQ-PEX | Meta Systems Co., Ltd. | 2021-10-20 | 218 | 0 |
| K203836 | BOMEDENT Apex locator, WISMY Apex locator | Changzhou Bomedent Medical Technology Co.,Ltd | 2021-03-30 | 90 | 0 |
| K191806 | Propex IQ Apex Locator | Dentsply Sirona | 2019-10-03 | 90 | 0 |
| K181087 | Apex Locator, DPEX III | Guilin Woodpecker Medical Instrument Co., Ltd. | 2018-12-18 | 237 | 0 |
| K171867 | Dr’s Finder NEO | Good Doctors Co., Ltd. | 2018-03-30 | 281 | 0 |
| K151274 | Dr's Finder | Good Doctors Co., Ltd. | 2016-02-04 | 267 | 0 |
| K131907 | RAYPEX 6 | Dentsply International, Inc. | 2014-01-31 | 219 | 0 |
| K121206 | DETECT | Forum Engineering Technologies, Ltd. | 2013-01-10 | 265 | 0 |
| K112508 | I-ROOT 100 | S-Denti Co., Ltd. | 2012-06-19 | 294 | 0 |
| K112153 | IROOT 100 MINI | S-Denti Co., Ltd. | 2012-04-26 | 294 | 0 |
| K111474 | BINGO PRO | Forum Engineering Technologies (96) , Ltd. | 2011-11-02 | 159 | 0 |
| K103123 | APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE | Micro-Mega Societe Anonyme | 2011-03-10 | 140 | 0 |
| K100450 | I-ROOT | S-Denti Co., Ltd. | 2010-11-18 | 274 | 0 |
| K101177 | APEXNRG RIDER | Medicnrg , Ltd. | 2010-10-08 | 164 | 0 |
| K101054 | ROMIAPEX MODEL A-15 | Romidan, Ltd. | 2010-09-03 | 141 | 0 |
| K090925 | MULTIPLE (APEX LOCATOR), MODEL RCM-7 | J. Morita USA, Inc. | 2009-11-23 | 235 | 0 |
| K083901 | NAVI ROOT | S-Denti Co., Ltd. | 2009-04-15 | 107 | 0 |
| K073185 | APX21 | Techdent Technologies, Ltd. | 2008-03-06 | 114 | 0 |
| K080113 | APEX DAL ELECTRONIC APEX LOCATOR | Medicnrg , Ltd. | 2008-02-15 | 30 | 0 |
| K071133 | APEXNRG-BLUE ELECTRONIC APEX LOCATOR | Medicnrg , Ltd. | 2007-09-21 | 151 | 0 |
| K063843 | APEXNRG XFR | Medicnrg , Ltd. | 2007-01-03 | 8 | 0 |
| K053235 | NSK PRECISION APEX LOCATOR (PAL) | Medicsense USA | 2006-01-24 | 67 | 0 |
| K032743 | APEX NRG | Medicnrg , Ltd. | 2004-03-15 | 193 | 0 |
| K030895 | ASEPTICO ENDOPEX V, MODEL AEU-40 | Aseptico, Inc. | 2003-12-03 | 257 | 0 |
| K022147 | DENTA PORT | J. Morita USA, Inc. | 2002-12-20 | 171 | 0 |
| K022020 | JUSTWO MODEL TME-601 ROOT APEX LOCATOR | Toei Electric Co., Ltd. | 2002-07-02 | 12 | 0 |
| K002195 | FORAMATRON V, MODEL D680 | Parkell, Inc. | 2000-08-30 | 41 | 0 |
| K992233 | APEX LOCATOR BINGO-1020 | Dent Corp. Research & Development | 1999-11-30 | 158 | 0 |
| K972407 | ROOT APEX LOCATOR | Toei Electric Co., Ltd. | 1997-09-11 | 77 | 0 |
| K962803 | APEX FINDER MODELS 7005 | Sybron Dental Specialties, Inc. | 1996-10-08 | 82 | 0 |
| K962853 | NEOSONO | L.S. Scientific | 1996-09-12 | 52 | 0 |
| K955088 | NEOSONO 2000 | American Medical & Dental Corp. | 1996-07-10 | 246 | 0 |
| K953867 | ROOT CANAL LENGTH MEASURING DEVICE | J. Morita USA, Inc. | 1995-12-01 | 106 | 0 |
| K950857 | FORAMATRON IV | Parkell, Inc. | 1995-04-20 | 52 | 0 |
| K945811 | PULPDENT CANAL FINDER | Pulpdent Corp. | 1995-01-20 | 53 | 0 |
| K921979 | ROOT ZX | J. Morita USA, Inc. | 1993-05-27 | 394 | 0 |
| K904742 | OSADA ENDEX | Osada Electric Co., Ltd. | 1990-12-17 | 60 | 0 |
| K890735 | COATED APEX PROBE | Analytic Technology | 1989-04-19 | 65 | 0 |
| K863393 | ENDOCATER | The Hygenic Corp. | 1987-06-11 | 281 | 0 |
| K864500 | ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001 | Analytic Technology | 1987-03-19 | 125 | 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