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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.

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
EHD
Device class
2
Regulation
872.1800
Medical specialty
Dental

Makers by country

CountryMakers
South Korea13
United States8
China7
Italy4
Finland2
Japan2
Taiwan2
India1
Germany1
Brazil1
Canada1
France1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Digimed Co., LtdSeoul, South KoreaManufacturer5March 3, 2023010api.fda.gov
Vatech Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer4October 26, 2022000api.fda.gov
Genoray Co., Ltd.Seongnam-si Gyeonggi, South KoreaManufacturer3December 8, 2023000api.fda.gov
Ningbo Runyes Medical Instrument Co., Ltd.Ningbo Zhejiang, ChinaManufacturer3February 3, 2026000api.fda.gov
Planmeca OyHelsinki Uusimaa, FinlandManufacturer3July 29, 2009000api.fda.gov
Skanray Technologies LimitedMysore Karnataka, IndiaContract manufacturer, Manufacturer3June 8, 2017000api.fda.gov
Takara Belmont CorporationOsaka, JapanComplaint file establishment, Specification developer3September 3, 2014000api.fda.gov
Takara Medical Co., Ltd.Amagasaki Hyogo, JapanComplaint file establishment, Manufacturer3September 3, 2014000api.fda.gov
Changzhou Sifary Medical Technology Co., Ltd.Changzhou Jiangsu, ChinaManufacturer2September 14, 2026000api.fda.gov
De Gotzen S.R.L.FAGNANO OLONA Varese, ItalyManufacturer2December 28, 2023000api.fda.gov
Dental Imaging Technologies CorporationQuakertown, PA, United StatesComplaint file establishment, Manufacturer2March 20, 2026000api.fda.gov
Guilin Woodpecker Medical Instrument Co., LtdGUILIN CITY Guangxi, ChinaManufacturer2September 4, 2025000api.fda.gov
HDX Will Corp.Heungdeok-gu, Cheongju-si, Chungcheongbuk-do Chungbuk, South KoreaManufacturer2December 27, 2019000api.fda.gov
Remedi Inc.Chuncheon Gangwon, South KoreaManufacturer2May 13, 2024000api.fda.gov
Sirona Dental Systems GMBHBENSHEIM Hesse, GermanyManufacturer2December 23, 2008000api.fda.gov
Xline SRLASSAGO Milano, ItalyComplaint file establishment, Manufacturer2August 23, 2022000api.fda.gov
Ads Dental System Inc.Ontario, CA, United StatesRemanufacturer1March 12, 2026000api.fda.gov
Alliage S/A Industrias Medico OdontologicaRibeirao Preto Sao Paulo, BrazilManufacturer1January 3, 2024000api.fda.gov
Beyes Dental IncToronto Ontario, CanadaManufacturer1July 8, 2003000api.fda.gov
Cefla S.C.IMOLA Bologna, ItalyManufacturer1January 13, 2017010api.fda.gov
Dhef Inc.New Taipei City, TaiwanManufacturer1April 24, 2006000api.fda.gov
DRTECH CorporationSeongnam-si Gyeonggi, South KoreaManufacturer1November 1, 2024000api.fda.gov
ECOTRON Co., Ltd.Seoul, South KoreaManufacturer1June 27, 2022000api.fda.gov
Guangzhou Ajax Medical Equipment Co LtdGuangzhou Guangdong, ChinaManufacturer1March 12, 2026000api.fda.gov
Guilin Refine Medical Instrument Co., Ltd.Guilin Guangxi, ChinaManufacturer1February 19, 2026000api.fda.gov
Livermoretech,incPlano, TX, United StatesManufacturer1December 19, 2019000api.fda.gov
Lucas Lifecare, LLCJanesville, WI, United StatesManufacturer1July 5, 2024000api.fda.gov
Midmark CorporationVersailles, OH, United StatesManufacturer1December 13, 2004000api.fda.gov
Osstem Implant Co., Ltd.Gangseo-gu Seoul, South KoreaSpecification developer1November 28, 2023000api.fda.gov
Osstem Implant Co.,ltd.Yeonsu-gu Incheon, South KoreaManufacturer1November 28, 2023000api.fda.gov
Palodex Group OYTuusula Uusimaa, FinlandManufacturer1July 13, 2000010api.fda.gov
PDX Co., Ltd.Anyang-Si Gyeonggi, South KoreaManufacturer1May 27, 2026000api.fda.gov
PICOPACK Inc.Daejeon, South KoreaManufacturer1July 30, 2024000api.fda.gov
Poskom Co., LtdGoyang-si Gyeonggi, South KoreaContract manufacturer, Manufacturer1July 31, 2013000api.fda.gov
Rolence Ent. Inc.CHUNGLI Taoyuan, TaiwanExporter to the US, Manufacturer1March 16, 2018000api.fda.gov
Shenzhen Xpectvision Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer1February 8, 2024000api.fda.gov
Trident SRLCastenedolo Brescia, ItalyManufacturer1September 13, 2018000api.fda.gov
TrophyMarne La Vallee Ile-de-France, FranceManufacturer1March 3, 2006000api.fda.gov
Valkyrie Bioscience, IncLindon, UT, United StatesComplaint file establishment, Specification developer1July 6, 2023000api.fda.gov
Vsi Co., Ltd.Cheongju-si Chungbuk, South KoreaManufacturer1June 29, 2022000api.fda.gov
iRay Imaging Technology (Haining) LimitedHaining Zhejiang, ChinaManufacturer1January 17, 2023000api.fda.gov
Dentsply LLCYork, PA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Turner Imaging Systems, Inc.Orem, UT, United StatesContract manufacturer0000api.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.