LQY
46 FDA 510(k) clearances · Product code
158 daysmedian time to decision
281 days90th percentile
46clearances measured
FDA profile
- Official device name
- Locator, Root Apex
- Device class
- Unclassified
- Medical specialty
- Unknown
- Adverse events (MAUDE)
- 2021: 107 · 2022: 63 · 2023: 56 · 2024: 81 · 2025: 52 · 2026: 38
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Apex Locator (FindPex) (K252224) | Changzhou Sifary Medical Technology Co., Ltd. | 2026-04-08 |
| Apex Locator (K242383) | Shenzhen Rogin Medical Co., Ltd. | 2025-03-07 |
| Electronic Apex Locator (Alpha Apex I) (K242765) | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | 2025-01-17 |
| Apex Locator (K231990) | Cefla S.C. | 2024-02-13 |
| Apex Locator (AL-Pex), Apex Locator (AL-Pex+) (K232717) | Changzhou Haili Medical Co., Ltd. | 2023-12-22 |
| Root Apex Locator (K212178) | Foshan Coxo Medical Instrument Co., Ltd. | 2022-07-20 |
| EQ-PEX (K210789) | Meta Systems Co., Ltd. | 2021-10-20 |
| BOMEDENT Apex locator, WISMY Apex locator (K203836) | Changzhou Bomedent Medical Technology Co.,Ltd | 2021-03-30 |
| Propex IQ Apex Locator (K191806) | Dentsply Sirona | 2019-10-03 |
| Apex Locator, DPEX III (K181087) | Guilin Woodpecker Medical Instrument Co., Ltd. | 2018-12-18 |
| Dr’s Finder NEO (K171867) | Good Doctors Co., Ltd. | 2018-03-30 |
| Dr's Finder (K151274) | Good Doctors Co., Ltd. | 2016-02-04 |
| RAYPEX 6 (K131907) | Dentsply International, Inc. | 2014-01-31 |
| DETECT (K121206) | Forum Engineering Technologies, Ltd. | 2013-01-10 |
| I-ROOT 100 (K112508) | S-Denti Co., Ltd. | 2012-06-19 |
| IROOT 100 MINI (K112153) | S-Denti Co., Ltd. | 2012-04-26 |
| BINGO PRO (K111474) | Forum Engineering Technologies (96) , Ltd. | 2011-11-02 |
| APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES) (K103123) | Micro-Mega Societe Anonyme | 2011-03-10 |
| I-ROOT (K100450) | S-Denti Co., Ltd. | 2010-11-18 |
| APEXNRG RIDER (K101177) | Medicnrg , Ltd. | 2010-10-08 |
| ROMIAPEX MODEL A-15 (K101054) | Romidan, Ltd. | 2010-09-03 |
| MULTIPLE (APEX LOCATOR), MODEL RCM-7 (K090925) | J. Morita USA, Inc. | 2009-11-23 |
| NAVI ROOT (K083901) | S-Denti Co., Ltd. | 2009-04-15 |
| APX21 (K073185) | Techdent Technologies, Ltd. | 2008-03-06 |
| APEX DAL ELECTRONIC APEX LOCATOR (K080113) | Medicnrg , Ltd. | 2008-02-15 |
| APEXNRG-BLUE ELECTRONIC APEX LOCATOR (K071133) | Medicnrg , Ltd. | 2007-09-21 |
| APEXNRG XFR (K063843) | Medicnrg , Ltd. | 2007-01-03 |
| NSK PRECISION APEX LOCATOR (PAL) (K053235) | Medicsense USA | 2006-01-24 |
| APEX NRG (K032743) | Medicnrg , Ltd. | 2004-03-15 |
| ASEPTICO ENDOPEX V, MODEL AEU-40 (K030895) | Aseptico, Inc. | 2003-12-03 |
| DENTA PORT (K022147) | J. Morita USA, Inc. | 2002-12-20 |
| JUSTWO MODEL TME-601 ROOT APEX LOCATOR (K022020) | Toei Electric Co., Ltd. | 2002-07-02 |
| FORAMATRON V, MODEL D680 (K002195) | Parkell, Inc. | 2000-08-30 |
| APEX LOCATOR BINGO-1020 (K992233) | Dent Corp. Research & Development | 1999-11-30 |
| ROOT APEX LOCATOR (K972407) | Toei Electric Co., Ltd. | 1997-09-11 |
| APEX FINDER MODELS 7005 (K962803) | Sybron Dental Specialties, Inc. | 1996-10-08 |
| NEOSONO (K962853) | L.S. Scientific | 1996-09-12 |
| NEOSONO 2000 (K955088) | American Medical & Dental Corp. | 1996-07-10 |
| ROOT CANAL LENGTH MEASURING DEVICE (K953867) | J. Morita USA, Inc. | 1995-12-01 |
| FORAMATRON IV (K950857) | Parkell, Inc. | 1995-04-20 |
| PULPDENT CANAL FINDER (K945811) | Pulpdent Corp. | 1995-01-20 |
| ROOT ZX (K921979) | J. Morita USA, Inc. | 1993-05-27 |
| OSADA ENDEX (K904742) | Osada Electric Co., Ltd. | 1990-12-17 |
| COATED APEX PROBE (K890735) | Analytic Technology | 1989-04-19 |
| ENDOCATER (K863393) | The Hygenic Corp. | 1987-06-11 |
| ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001 (K864500) | Analytic Technology | 1987-03-19 |
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