Data / Medical devices / Unit, X-Ray, Extraoral With Timer
Unit, X-Ray, Extraoral With Timer (EHD): 43 FDA-registered makers in 12 countries
43 establishments in 12 countries are registered with the FDA to make Unit, X-Ray, Extraoral With Timer (product code EHD, Class 2, 21 CFR 872.1800). 41 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 191 510(k) clearances under this code, the latest on September 14, 2026, and lists 15 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EHD
- Device class
- 2
- Regulation
- 872.1800
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| South Korea | 13 |
| United States | 8 |
| China | 7 |
| Italy | 4 |
| Finland | 2 |
| Japan | 2 |
| Taiwan | 2 |
| India | 1 |
| Germany | 1 |
| Brazil | 1 |
| Canada | 1 |
| France | 1 |
Makers of Unit, X-Ray, Extraoral With Timer
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 |
|---|---|---|---|---|---|---|---|---|
| Digimed Co., Ltd | Seoul, South Korea | Manufacturer | 5 | March 3, 2023 | 0 | 1 | 0 | api.fda.gov |
| Vatech Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 4 | October 26, 2022 | 0 | 0 | 0 | api.fda.gov |
| Genoray Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 3 | December 8, 2023 | 0 | 0 | 0 | api.fda.gov |
| Ningbo Runyes Medical Instrument Co., Ltd. | Ningbo Zhejiang, China | Manufacturer | 3 | February 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| Planmeca Oy | Helsinki Uusimaa, Finland | Manufacturer | 3 | July 29, 2009 | 0 | 0 | 0 | api.fda.gov |
| Skanray Technologies Limited | Mysore Karnataka, India | Contract manufacturer, Manufacturer | 3 | June 8, 2017 | 0 | 0 | 0 | api.fda.gov |
| Takara Belmont Corporation | Osaka, Japan | Complaint file establishment, Specification developer | 3 | September 3, 2014 | 0 | 0 | 0 | api.fda.gov |
| Takara Medical Co., Ltd. | Amagasaki Hyogo, Japan | Complaint file establishment, Manufacturer | 3 | September 3, 2014 | 0 | 0 | 0 | api.fda.gov |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou Jiangsu, China | Manufacturer | 2 | September 14, 2026 | 0 | 0 | 0 | api.fda.gov |
| De Gotzen S.R.L. | FAGNANO OLONA Varese, Italy | Manufacturer | 2 | December 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Dental Imaging Technologies Corporation | Quakertown, PA, United States | Complaint file establishment, Manufacturer | 2 | March 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Guilin Woodpecker Medical Instrument Co., Ltd | GUILIN CITY Guangxi, China | Manufacturer | 2 | September 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| HDX Will Corp. | Heungdeok-gu, Cheongju-si, Chungcheongbuk-do Chungbuk, South Korea | Manufacturer | 2 | December 27, 2019 | 0 | 0 | 0 | api.fda.gov |
| Remedi Inc. | Chuncheon Gangwon, South Korea | Manufacturer | 2 | May 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Sirona Dental Systems GMBH | BENSHEIM Hesse, Germany | Manufacturer | 2 | December 23, 2008 | 0 | 0 | 0 | api.fda.gov |
| Xline SRL | ASSAGO Milano, Italy | Complaint file establishment, Manufacturer | 2 | August 23, 2022 | 0 | 0 | 0 | api.fda.gov |
| Ads Dental System Inc. | Ontario, CA, United States | Remanufacturer | 1 | March 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Alliage S/A Industrias Medico Odontologica | Ribeirao Preto Sao Paulo, Brazil | Manufacturer | 1 | January 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Beyes Dental Inc | Toronto Ontario, Canada | Manufacturer | 1 | July 8, 2003 | 0 | 0 | 0 | api.fda.gov |
| Cefla S.C. | IMOLA Bologna, Italy | Manufacturer | 1 | January 13, 2017 | 0 | 1 | 0 | api.fda.gov |
| Dhef Inc. | New Taipei City, Taiwan | Manufacturer | 1 | April 24, 2006 | 0 | 0 | 0 | api.fda.gov |
| DRTECH Corporation | Seongnam-si Gyeonggi, South Korea | Manufacturer | 1 | November 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| ECOTRON Co., Ltd. | Seoul, South Korea | Manufacturer | 1 | June 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou Guangdong, China | Manufacturer | 1 | March 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Guilin Refine Medical Instrument Co., Ltd. | Guilin Guangxi, China | Manufacturer | 1 | February 19, 2026 | 0 | 0 | 0 | api.fda.gov |
| Livermoretech,inc | Plano, TX, United States | Manufacturer | 1 | December 19, 2019 | 0 | 0 | 0 | api.fda.gov |
| Lucas Lifecare, LLC | Janesville, WI, United States | Manufacturer | 1 | July 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| Midmark Corporation | Versailles, OH, United States | Manufacturer | 1 | December 13, 2004 | 0 | 0 | 0 | api.fda.gov |
| Osstem Implant Co., Ltd. | Gangseo-gu Seoul, South Korea | Specification developer | 1 | November 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Osstem Implant Co.,ltd. | Yeonsu-gu Incheon, South Korea | Manufacturer | 1 | November 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Palodex Group OY | Tuusula Uusimaa, Finland | Manufacturer | 1 | July 13, 2000 | 0 | 1 | 0 | api.fda.gov |
| PDX Co., Ltd. | Anyang-Si Gyeonggi, South Korea | Manufacturer | 1 | May 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| PICOPACK Inc. | Daejeon, South Korea | Manufacturer | 1 | July 30, 2024 | 0 | 0 | 0 | api.fda.gov |
| Poskom Co., Ltd | Goyang-si Gyeonggi, South Korea | Contract manufacturer, Manufacturer | 1 | July 31, 2013 | 0 | 0 | 0 | api.fda.gov |
| Rolence Ent. Inc. | CHUNGLI Taoyuan, Taiwan | Exporter to the US, Manufacturer | 1 | March 16, 2018 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Xpectvision Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | February 8, 2024 | 0 | 0 | 0 | api.fda.gov |
| Trident SRL | Castenedolo Brescia, Italy | Manufacturer | 1 | September 13, 2018 | 0 | 0 | 0 | api.fda.gov |
| Trophy | Marne La Vallee Ile-de-France, France | Manufacturer | 1 | March 3, 2006 | 0 | 0 | 0 | api.fda.gov |
| Valkyrie Bioscience, Inc | Lindon, UT, United States | Complaint file establishment, Specification developer | 1 | July 6, 2023 | 0 | 0 | 0 | api.fda.gov |
| Vsi Co., Ltd. | Cheongju-si Chungbuk, South Korea | Manufacturer | 1 | June 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| iRay Imaging Technology (Haining) Limited | Haining Zhejiang, China | Manufacturer | 1 | January 17, 2023 | 0 | 0 | 0 | api.fda.gov |
| Dentsply LLC | York, PA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turner Imaging Systems, Inc. | Orem, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 14, 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.