Data / Medical devices / Prosthesis, Orthodontic
Prosthesis, Orthodontic (NSR): 46 FDA-registered makers in 10 countries
46 establishments in 10 countries are registered with the FDA to make Prosthesis, Orthodontic (product code NSR, Class N). 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 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NSR
- Device class
- N
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| China | 26 |
| India | 6 |
| Vietnam | 3 |
| United States | 3 |
| Costa Rica | 2 |
| Hong Kong | 2 |
| Canada | 1 |
| Thailand | 1 |
| Taiwan | 1 |
| South Korea | 1 |
Makers of Prosthesis, Orthodontic
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 |
|---|---|---|---|---|---|---|---|---|
| Aceso Dental Laboratory Company Limited | An Phuoc Ward Dong Nai, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bright Dental Lab | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CBD Dental Lab, Inc | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Creator Digital Dental Technology Co.ltd | Zhuhai Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DDS Lab Costa Rica Sociedad Amonima | Grecia Alajuela, Costa Rica | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DDS Lab China Co, LTD | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentcare Dental Lab Pvt. Ltd. | ERNAKULAM Kerala, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digital Dental Depot | zhuhai Guangdong, China | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digital Dental Depot Limited | Hong Kong, Hong Kong | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DTS Digital Dental Lab | shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digital Dental Laboratories, DBA Orthodent | Oshawa Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edental Lab Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Exceldent Dental Technology Development Co., Ltd. | Zhuhai Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| F-Six Dental Technology Co.,limited | Central Hong Kong, Hong Kong | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fseven Dental Technology Zhuhai Co.,ltd | ZHUHAI Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hexa Ceram Co., Ltd. | Sansai Chiang Mai, Thailand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiyi Dental Laboratory | Changhua, Taiwan | Contract 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 | |
| Kamal Encon Industries Limited | Faridabad Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KTJ Dental Lab Inc | Los Angeles, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| KTJ Medical Technology Co.,Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laboratorios Dentales De Zona Franca, S.A. | Cartago, Costa Rica | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laxmi Dental Lab Usa Inc. | Kenilworth, NJ, United States | Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| League Dental Technology Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Libral Traders Pvt. Ltd. | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laxmi Dental Limited | Palghar Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S Leixir Resources Pvt. Ltd | GURUGRAM Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modern Dental Laboratory (DG) Co., Ltd. | Dongguan Guangdong, China | 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 | |
| One Day Dental Partner | Suncheon-si Jeonnam, South Korea | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Royal Dental Lab | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shen Fu Arts Lab | Shen Zhen Guangdong, 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 Jinyi Medical 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 | |
| Shimmer Computerized Dental Technology Co.,ltd | Zhuhai Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smile Dental Laboratory Company Limited | Zhuhai Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smile Stones Dental Pvt Ltd | MADURAI Tamil Nadu, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sun Dental Laboratories LLC | Saint Petersburg, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thanh Dental Laboratory | ho chi minh city, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tin Lok (Dongguan) Dental Laboratory Company Limited | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Veden Dental Labs Inc | Zhuhai Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vico Dental Technology Co. Ltd | DongGuan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZH Graceful Dental Lab Co., Ltd. | Zhuhai Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhuhai Crystal Dental Technology Co.,ltd | Zhuhai Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhuhai MJ Dental Laboratory | Zhuhai Guangdong, 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.