Data / Medical devices / Teeth, Artificial, Posterior With Metal Insert
Teeth, Artificial, Posterior With Metal Insert (ELJ): 32 FDA-registered makers in 7 countries
32 establishments in 7 countries are registered with the FDA to make Teeth, Artificial, Posterior With Metal Insert (product code ELJ, Class 1, 21 CFR 872.3900). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ELJ
- Device class
- 1
- Regulation
- 872.3900
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| China | 15 |
| South Korea | 7 |
| United States | 4 |
| Canada | 2 |
| Vietnam | 2 |
| United Arab Emirates | 1 |
| Netherlands | 1 |
Makers of Teeth, Artificial, Posterior With Metal Insert
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 |
|---|---|---|---|---|---|---|---|---|
| Arak Dental Lab | Sharjah Dubayy, United Arab Emirates | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aurum Ceramic Dental Laboratories LLC | Spokane, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aurum Ceramic Dental Laboratories Ltd. | CALGARY Alberta, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Classic Dental Laboratories Ltd. | OTTAWA Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cometech VN Company Limited | Phu Thanh Ward Ho Chi Minh, Vietnam | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Crown Makers | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DIO Corporation | Haeundae-gu Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Thales Medtech Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huile Denture Technology(hongkong)co,limited | HONG KONG Hong Kong, China | Contract sterilizer, Exporter to the US, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Improve Co.,limited | Lantau Island Hong Kong, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovaid Co. | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integrity Dental Services LLC | Duluth, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Istar Dental Lab | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Joydenta Dental Laboratory | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nam A Dental Medicine Company Limited | Thong Tay Hoi Ward Ho Chi Minh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanjing Chamlion Laser Technology Co., Ltd. | Nanjing Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| One Day Dental Partner | Suncheon-si Jeonnam, South Korea | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Perfect Crown Dental Lab | Maspeth, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ray Co., Ltd | Yongin-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rite Smile Labs | Shenzhenzs Inner Mongolia, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen HLD Dental&technology Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Times Dental Lab | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SMD Dental Laboratory | Heungdeok-gu Cheongju-si Chungbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smile Dental Laboratory Company Limited | Zhuhai Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunrise Dental Laboratory, Ltd. | Kowloon, Hong Kong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunstar Trading International Limited | Kowloon Hong Kong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai dental labs INC. | Shanghai, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vericom Co., Ltd. | Chuncheon-Si Gangwon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vertex-Dental B.V. | Soesterberg Utrecht, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wellstone Dental LLC | Buena Park, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiao Fei Dental Manufacture (Chengdu) Co.Ltd | CHENGDU Sichuan, 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.