Data / Medical devices / Locator, Root Apex
Locator, Root Apex (LQY): 27 FDA-registered makers in 9 countries
27 establishments in 9 countries are registered with the FDA to make Locator, Root Apex (product code LQY, Class U). 18 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 46 510(k) clearances under this code, the latest on April 8, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- LQY
- Device class
- U
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| China | 8 |
| Japan | 4 |
| United States | 3 |
| Germany | 3 |
| Israel | 2 |
| South Korea | 2 |
| Italy | 2 |
| Austria | 2 |
| Canada | 1 |
Makers of Locator, Root Apex
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Micro Diamond Technologies Ltd.- Medicnrg Ltd. | AFULA Northern, Israel | Manufacturer | 4 | October 8, 2010 | 0 | 0 | 0 | api.fda.gov |
| Forum Engineering Technologies (96) Ltd. | Ashkelon Southern, Israel | Manufacturer | 3 | January 10, 2013 | 0 | 0 | 0 | api.fda.gov |
| Coltene/Whaledent Inc. | Cuyahoga Falls, OH, United States | Manufacturer, Specification developer | 2 | November 2, 2011 | 0 | 0 | 0 | api.fda.gov |
| Good Doctors Co., Ltd. | Incheon Seoul, South Korea | Manufacturer | 2 | March 30, 2018 | 0 | 0 | 0 | api.fda.gov |
| META SYSTEMS CO., LTD also doing business as S-Denti Co.,Ltd | Seongnam-si Gyeonggi, South Korea | Manufacturer | 2 | October 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Beyes Dental Inc | Toronto Ontario, Canada | Manufacturer | 1 | December 18, 2018 | 0 | 0 | 0 | api.fda.gov |
| Cefla S.C. | IMOLA Bologna, Italy | Manufacturer | 1 | February 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Changzhou Bomedent Medical Technology Co., Ltd | Changzhou Jiangsu, China | Manufacturer | 1 | March 30, 2021 | 0 | 0 | 0 | api.fda.gov |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou Jiangsu, China | Manufacturer | 1 | April 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan Guangdong, China | Manufacturer | 1 | July 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| Guilin Woodpecker Medical Instrument Co., Ltd | GUILIN CITY Guangxi, China | Manufacturer | 1 | December 18, 2018 | 0 | 0 | 0 | api.fda.gov |
| J. Morita MFG. Corp. | FUSHIMI-KU Kyoto, Japan | Manufacturer | 1 | November 23, 2009 | 0 | 0 | 0 | api.fda.gov |
| Nakanishi Inc. | Kanuma Tochigi, Japan | Manufacturer | 1 | January 24, 2006 | 0 | 0 | 0 | api.fda.gov |
| Osada Electric Co., Ltd. | SHINAGAWA-KU Tokyo, Japan | Manufacturer | 1 | December 17, 1990 | 0 | 0 | 0 | api.fda.gov |
| Parkell, Inc. | Edgewood, NY, United States | Manufacturer | 1 | August 30, 2000 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Rogin Medical Co., Ltd | shenzhen Guangdong, China | Exporter to the US, Manufacturer | 1 | March 7, 2025 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Superline Technology Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 1 | January 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| VDW GMBH | MUNICH Bavaria, Germany | Specification developer | 1 | January 31, 2014 | 0 | 0 | 0 | api.fda.gov |
| Advanced Technology Research S.R.L. | Pistoia, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Asi Medical, Inc. | Englewood, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Denjoy Dental Co., Ltd | Changsha city Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanko Electronics Corporation | Midori Gunma, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Schlumbohm GMBH & Co. KG | Brokstedt Schleswig-Holstein, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Perfect Medical Instruments Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sirona Dental Systems GMBH | BENSHEIM Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| W&H Dentalwerk Buermoos GMBH | BUERMOOS Salzburg, Austria | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| W&H Dentalwerk Buermoos GMBH - Site 2 | BUERMOOS Salzburg, Austria | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.