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
| Country | Makers |
|---|---|
| United States | 18 |
| China | 15 |
| South Korea | 8 |
| Japan | 4 |
| Italy | 3 |
| Taiwan | 3 |
| Germany | 3 |
| Brazil | 2 |
| Canada | 2 |
| Finland | 1 |
| Vietnam | 1 |
| France | 1 |
| Mexico | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| A-dec, Inc. | Newberg, OR, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 1 | July 14, 1989 | 0 | 0 | 0 | api.fda.gov |
| Alliage S/A Industrias Medico Odontologica | Ribeirao Preto Sao Paulo, Brazil | Manufacturer | 1 | September 29, 1986 | 0 | 0 | 0 | api.fda.gov |
| Den-Mat Holdings, LLC | Lompoc, CA, United States | Complaint file establishment, Specification developer | 1 | November 22, 2004 | 0 | 0 | 0 | api.fda.gov |
| Planmeca Oy | Helsinki Uusimaa, Finland | Manufacturer | 1 | December 21, 1992 | 0 | 0 | 0 | api.fda.gov |
| Summit Dental Systems LLC. | Fort Lauderdale, FL, United States | Manufacturer | 1 | September 29, 1986 | 0 | 0 | 0 | api.fda.gov |
| Addent, Inc. | Danbury, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aiobio Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Complaint file establishment, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aopu Lighting (jinyun) Co., Ltd. | Lishui Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ascentcare Dental Products | Grand Haven, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aseptico, Inc. | Woodinville, WA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beaverstate Dental, Inc. | Newberg, OR, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Belmont Techno Kyoto Corporation | Yawata Kyoto, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beyes Dental Inc | Toronto Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Belmont Manufacturing Co., Ltd. | Dong Nai, Vietnam | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cefla S.C. | IMOLA Bologna, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chuan Fu Medical Instrument Co., Ltd | Taoyuan City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DCI International, LLC | Newberg, OR, United States | Manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Dental Monitoring | PARIS Ile-de-France, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dental Technologies, Inc. | Lincolnwood, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentalez Of Alabama | Bay Minette, AL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentis Medical Division | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentozone Corporation | Guro-gu Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dexta Corp. | Napa, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dhef Inc. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dntlworks Equipment Corp. | Centennial, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Doiff Co., Ltd. | Suncheon-si, Jeollanam-do Jeonnam, South Korea | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Wanjin Industrial Co., Ltd | DongGuang Guangdong, China | Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DXM Co., Ltd. | Jeonnam-Gwangju Special Metropolitan City, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epdent Co., Ltd. | Gimpo-city Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ergonomic Products, Inc. | Fall River, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Faro S.P.A. | Ornago (MB) Milano, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FDC Technology Industry Company | Taishan,GUANG CHONG Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Forefront (xiamen) Medical Devices Co., Ltd. | Xiamen Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Forest Dental Equipment | Bay Minette, AL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gavin Biotechnology Co.,ltd | Jinzhong Shanxi, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Wise Medical Device Co.,ltd | Hangzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Henan Baistra Medical Devices Limited | Zhengzhou Henan, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J. Morita MFG. Corp. | FUSHIMI-KU Kyoto, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kavo Dental GMBH | WARTHAUSEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kuang Yeu Medical Co., Ltd. | Taichung City, TAIWAN, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lakong Medical Devices Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Manufacturera Dental Continental | ZAPOPAN Jalisco, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mastercraft Dental Co. Of Texas | Midlothian, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medfruition Electronics Technology Co., Ltd | Foshan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Midmark Corporation | Versailles, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MegaGen Implant Co., Ltd. (Secheon 2nd factory) | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olsen Industria E Comercio S/A | Palhoca Santa Catarina, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oralkleen LLC | Phoenix, AZ, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Proma, Inc. | Carson, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Safari Dental, Inc. | BOISBRIAND Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Greeloy Industry Co., Ltd | Shanghai, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Denco Medical Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Rogin Medical Co., Ltd | shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Silfradent SRL | S.Sofia Forli, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sinol Dental Limited | Xianyang Shaanxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sirona Dental Systems GMBH | BENSHEIM Hesse, Germany | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Takara Belmont Corporation | Osaka, Japan | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Takara Belmont Corporation, Osaka Factory | Osaka, Japan | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WHR Hossinger Kunststofftechnik GMBH | Roding Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xenosys Co., Ltd. | Incheon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.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.