Data / Medical devices / Chair, Dental, Without Operative Unit
Chair, Dental, Without Operative Unit (NRU): 83 FDA-registered makers in 13 countries
83 establishments in 13 countries are registered with the FDA to make Chair, Dental, Without Operative Unit (product code NRU, Class 1, 21 CFR 872.6250). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NRU
- Device class
- 1
- Regulation
- 872.6250
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| China | 32 |
| United States | 23 |
| South Korea | 8 |
| Italy | 4 |
| Canada | 3 |
| India | 3 |
| Brazil | 2 |
| Taiwan | 2 |
| Japan | 2 |
| Vietnam | 1 |
| Mexico | 1 |
| Malaysia | 1 |
| Finland | 1 |
Makers of Chair, Dental, Without Operative Unit
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 | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| A.R. Medicom Inc. (Shanghai) Co., Ltd. | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ac Equipamentos Medicos E Odontologicos Ltda | Ribeirao Preto Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AMD Medicom Inc. | Pointe-Claire, Montreal Quebec, Canada | Complaint file establishment, Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui JM Healthcare Products Co.,ltd. | Shouxian Anhui, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anqing Clean Dental Instrument Technology Co.,ltd | Anqing City Anhui, China | Exporter to the US, 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 | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beyes Dental Inc | Toronto Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BGSS Company Asia Limited | Zhabei Shanghai, China | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| BH Medical Products Co., Ltd | Changzhou City Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boyd Industries, Inc. | Clearwater, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Belmont Manufacturing Co., Ltd. | Dong Nai, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Calibaja Manufacturing, S.A. De C.V. | MEXICALI Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cefla S.C. | IMOLA Bologna, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Crosstex International, Inc. | Sharon, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Shengjie Medical Product Co., Ltd | Changzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Crosstex International | Rush, NY, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Danyang New Hope Medical Equipment Co., Ltd | Danyang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DCI International, LLC | Newberg, OR, United States | Manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Debo Medical Technology (shijiazhuang) Co., Ltd. | Shijiazhuang Hebei, China | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentalez Of Alabama | Bay Minette, AL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentis Medical Division | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentis Medical Division | Dong-gu Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dexta Corp. | Napa, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dntlworks Equipment Corp. | Centennial, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dome Inc | Tarzana, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Wanjin Industrial Co., Ltd | DongGuang Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dukal LLC | Ronkonkoma, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ergonomic Products, Inc. | Fall River, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Euronda SPA | Sandrigo Vicenza, 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 | |
| Forest Dental Equipment | Bay Minette, AL, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Any Home Care Medical Technology Co.,ltd. | Foshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greatcare 4u Sdn Bhd | Selangor Darul Ehsan, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan Guangdong, China | 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 | |
| Hallim Point Implant Co., Ltd | SIHEUNG-SI Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hdi Inc. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hefei Jingcheng Plastic Products Co. Ltd | Hefei Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd | Qianjiang, Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hefei Xingcheng Sanitary Products CO.,LTD | Hefei Anhui, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Dynamic Medical Technology Co., Ltd | Suzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangyin Huaying Light Industrial Products Co., LTD | Jiangyin Jiangsu, China | Contract manufacturer, 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 | |
| Mark Enterprises | Nashik Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marken Healthtech Limited | NASHIK Maharashtra, India | 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 | |
| Medical Technology Industries, Inc. | Salt Lake City, UT, United States | 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 | |
| Nucare LLC | Montclair, CA, United States | Specification developer | 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 | |
| Omnia SRL | FIDENZA Parma, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onvet Medical Canada Inc | TORONTO Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osstem Implant Co., Ltd. | Gangseo-gu Seoul, South Korea | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osstem Implant Co.,ltd. | Yeonsu-gu Incheon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| P Bhogilal Pvt Ltd | Kolkata West Bengal, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Palmero Healthcare LLC | Northbrook, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Petoskey Plastics | Petoskey, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plasdent Shanghai Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premium Plus (dongguan) Limited | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Planmeca Oy | Helsinki Uusimaa, Finland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ready Set Import | Beverly Hills, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Royal Dental MFG., Inc. | Everett, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Dental Instrument Factory Co., Ltd. | Shanghai, China | 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 | |
| Shengiho Enterprise Co., Ltd. | Taichung City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shinhung Co. Ltd. | Ansan-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sinol Dental Limited | Xianyang Shaanxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Summit Dental Systems LLC. | Fort Lauderdale, FL, United States | Manufacturer | 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 | |
| Tecnodent SRL | Casalecchio di Reno Bologna, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TF New Material Sci And Tec Co.,ltd | Huainan Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tianjin Water Source Tech Co., Ltd. | Tianjin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiantao S&J Protective Products Co., Ltd | Xiantao Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yueying Medical Instruments (langfang) Co., Ltd. | Langfang City Hebei, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yongqing Huaguan Dental Instruments Factory | Langfang City Hebei, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhangjiagang Bitoor Co., Ltd | ZHANGJIAGANG Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhangjiagang Blackbox Plastic Products Co., Ltd | ZhangJiaGang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZOGEAR Medical Co., Ltd. | Yizheng Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.