FDA product code LQY: Locator, Root Apex
LQY is the FDA product code for locator, root apex. It is a Unclassified device, reviewed by the Dental panel. FDA has cleared 46 510(k) submissions under LQY, 6 in the last five years, from 32 different applicants. The average 510(k) review took 165 days (median 154); 218 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Locator, Root Apex |
| Device class | Unclassified |
| Review panel | DE — Dental |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for LQY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 259 |
| 2019 | 1 | 90 |
| 2021 | 2 | 154 |
| 2022 | 1 | 373 |
| 2023 | 1 | 108 |
| 2024 | 1 | 223 |
| 2025 | 2 | 166 |
| 2026 | 1 | 266 |
Compare with all 510(k) review times · Search every LQY clearance
Top LQY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medicnrg , Ltd. | 5 | 2010-10-08 |
| S-Denti Co., Ltd. | 4 | 2012-06-19 |
| J. Morita USA, Inc. | 4 | 2009-11-23 |
| Good Doctors Co., Ltd. | 2 | 2018-03-30 |
| Toei Electric Co., Ltd. | 2 | 2002-07-02 |
27 more applicants have LQY clearances. See the full list in Caduvo.
Most recent LQY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252224 | Changzhou Sifary Medical Technology Co., Ltd. | Apex Locator (FindPex) | 2026-04-08 | 266 |
| K242383 | Shenzhen Rogin Medical Co., Ltd. | Apex Locator | 2025-03-07 | 207 |
| K242765 | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | Electronic Apex Locator (Alpha Apex I) | 2025-01-17 | 126 |
| K231990 | Cefla S.C. | Apex Locator | 2024-02-13 | 223 |
| K232717 | Changzhou Haili Medical Co., Ltd. | Apex Locator (AL-Pex), Apex Locator (AL-Pex+) | 2023-12-22 | 108 |
Recalls for LQY devices
openFDA lists no recalls for product code LQY.
Frequently asked questions
What is FDA product code LQY?
LQY is the FDA product code for locator, root apex. It is a Unclassified device, reviewed by the Dental panel.
What device class is LQY?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LQY?
Across 46 cleared submissions the average was 165 days from receipt to decision (median 154).
Which companies have the most LQY clearances?
Medicnrg , Ltd. (5); S-Denti Co., Ltd. (4); J. Morita USA, Inc. (4); Good Doctors Co., Ltd. (2); Toei Electric Co., Ltd. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code LQY
- Run a recall and safety report across every LQY manufacturer
- Watch product code LQY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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