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Data / Medical devices / Light, Operating, Dental

Light, Operating, Dental (EAZ): 62 FDA-registered makers in 13 countries

62 establishments in 13 countries are registered with the FDA to make Light, Operating, Dental (product code EAZ, Class 1, 21 CFR 872.4630). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 23 510(k) clearances under this code, the latest on November 19, 2007, and lists 3 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
EAZ
Device class
1
Regulation
872.4630
Medical specialty
Dental

Makers by country

CountryMakers
United States18
China15
South Korea8
Japan4
Italy3
Taiwan3
Germany3
Brazil2
Canada2
Finland1
Vietnam1
France1
Mexico1

Makers of Light, Operating, Dental

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
A-dec, Inc.Newberg, OR, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1July 14, 1989000api.fda.gov
Alliage S/A Industrias Medico OdontologicaRibeirao Preto Sao Paulo, BrazilManufacturer1September 29, 1986000api.fda.gov
Den-Mat Holdings, LLCLompoc, CA, United StatesComplaint file establishment, Specification developer1November 22, 2004000api.fda.gov
Planmeca OyHelsinki Uusimaa, FinlandManufacturer1December 21, 1992000api.fda.gov
Summit Dental Systems LLC.Fort Lauderdale, FL, United StatesManufacturer1September 29, 1986000api.fda.gov
Addent, Inc.Danbury, CT, United StatesManufacturer0000api.fda.gov
Aiobio Co., Ltd.Seongnam-si Gyeonggi, South KoreaComplaint file establishment, Exporter to the US, Manufacturer0000api.fda.gov
Aopu Lighting (jinyun) Co., Ltd.Lishui Zhejiang, ChinaManufacturer0000api.fda.gov
Ascentcare Dental ProductsGrand Haven, MI, United StatesManufacturer0000api.fda.gov
Aseptico, Inc.Woodinville, WA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Beaverstate Dental, Inc.Newberg, OR, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Belmont Techno Kyoto CorporationYawata Kyoto, JapanContract manufacturer0000api.fda.gov
Beyes Dental IncToronto Ontario, CanadaManufacturer0000api.fda.gov
Belmont Manufacturing Co., Ltd.Dong Nai, VietnamComplaint file establishment, Manufacturer0000api.fda.gov
Cefla S.C.IMOLA Bologna, ItalyManufacturer0000api.fda.gov
Chuan Fu Medical Instrument Co., LtdTaoyuan City, TaiwanManufacturer0000api.fda.gov
DCI International, LLCNewberg, OR, United StatesManufacturer0020api.fda.gov
Dental MonitoringPARIS Ile-de-France, FranceManufacturer0000api.fda.gov
Dental Technologies, Inc.Lincolnwood, IL, United StatesContract manufacturer0000api.fda.gov
Dentalez Of AlabamaBay Minette, AL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Dentis Medical DivisionDaegu, South KoreaManufacturer0000api.fda.gov
Dentozone CorporationGuro-gu Seoul, South KoreaManufacturer0000api.fda.gov
Dexta Corp.Napa, CA, United StatesManufacturer0000api.fda.gov
Dhef Inc.New Taipei City, TaiwanManufacturer0000api.fda.gov
Dntlworks Equipment Corp.Centennial, CO, United StatesManufacturer0000api.fda.gov
Doiff Co., Ltd.Suncheon-si, Jeollanam-do Jeonnam, South KoreaContract manufacturer, Manufacturer0000api.fda.gov
Dongguan Wanjin Industrial Co., LtdDongGuang Guangdong, ChinaRemanufacturer0000api.fda.gov
DXM Co., Ltd.Jeonnam-Gwangju Special Metropolitan City, South KoreaManufacturer0000api.fda.gov
Epdent Co., Ltd.Gimpo-city Gyeonggi, South KoreaManufacturer0000api.fda.gov
Ergonomic Products, Inc.Fall River, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Faro S.P.A.Ornago (MB) Milano, ItalyManufacturer0000api.fda.gov
FDC Technology Industry CompanyTaishan,GUANG CHONG Guangdong, ChinaManufacturer0000api.fda.gov
Forefront (xiamen) Medical Devices Co., Ltd.Xiamen Fujian, ChinaContract manufacturer0000api.fda.gov
Forest Dental EquipmentBay Minette, AL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Foshan Coxo Medical Instrument Co., Ltd.Foshan Guangdong, ChinaManufacturer0000api.fda.gov
Gavin Biotechnology Co.,ltdJinzhong Shanxi, ChinaExporter to the US, Manufacturer0000api.fda.gov
Guangzhou Ajax Medical Equipment Co LtdGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Hangzhou Wise Medical Device Co.,ltdHangzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Henan Baistra Medical Devices LimitedZhengzhou Henan, ChinaExporter to the US, Manufacturer0000api.fda.gov
J. Morita MFG. Corp.FUSHIMI-KU Kyoto, JapanManufacturer0000api.fda.gov
Kavo Dental GMBHWARTHAUSEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Kuang Yeu Medical Co., Ltd.Taichung City, TAIWAN, TaiwanManufacturer0000api.fda.gov
Lakong Medical Devices Co., Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
Manufacturera Dental ContinentalZAPOPAN Jalisco, MexicoManufacturer0000api.fda.gov
Mastercraft Dental Co. Of TexasMidlothian, TX, United StatesManufacturer0000api.fda.gov
Medfruition Electronics Technology Co., LtdFoshan City Guangdong, ChinaManufacturer0000api.fda.gov
Midmark CorporationVersailles, OH, United StatesManufacturer0000api.fda.gov
MegaGen Implant Co., Ltd. (Secheon 2nd factory)Daegu, South KoreaManufacturer0000api.fda.gov
Olsen Industria E Comercio S/APalhoca Santa Catarina, BrazilManufacturer0000api.fda.gov
Oralkleen LLCPhoenix, AZ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Proma, Inc.Carson, CA, United StatesManufacturer0000api.fda.gov
Safari Dental, Inc.BOISBRIAND Quebec, CanadaManufacturer0000api.fda.gov
Shanghai Greeloy Industry Co., LtdShanghai, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Denco Medical Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Rogin Medical Co., Ltdshenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Silfradent SRLS.Sofia Forli, ItalyManufacturer0000api.fda.gov
Sinol Dental LimitedXianyang Shaanxi, ChinaManufacturer0000api.fda.gov
Sirona Dental Systems GMBHBENSHEIM Hesse, GermanyManufacturer, Specification developer0000api.fda.gov
Takara Belmont CorporationOsaka, JapanComplaint file establishment, Specification developer0000api.fda.gov
Takara Belmont Corporation, Osaka FactoryOsaka, JapanComplaint file establishment, Manufacturer0000api.fda.gov
WHR Hossinger Kunststofftechnik GMBHRoding Bavaria, GermanyContract manufacturer0000api.fda.gov
Xenosys Co., Ltd.Incheon, South KoreaManufacturer0000api.fda.gov

Updated November 19, 2007. 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.