Skip to the page

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.

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
NSR
Device class
N
Medical specialty
Unknown

Makers by country

CountryMakers
China26
India6
Vietnam3
United States3
Costa Rica2
Hong Kong2
Canada1
Thailand1
Taiwan1
South Korea1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Aceso Dental Laboratory Company LimitedAn Phuoc Ward Dong Nai, VietnamManufacturer0000api.fda.gov
Bright Dental LabShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
CBD Dental Lab, IncShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Creator Digital Dental Technology Co.ltdZhuhai Guangdong, ChinaManufacturer0000api.fda.gov
DDS Lab Costa Rica Sociedad AmonimaGrecia Alajuela, Costa RicaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
DDS Lab China Co, LTDShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Dentcare Dental Lab Pvt. Ltd.ERNAKULAM Kerala, IndiaManufacturer0000api.fda.gov
Digital Dental Depotzhuhai Guangdong, ChinaContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Digital Dental Depot LimitedHong Kong, Hong KongContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
DTS Digital Dental Labshenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Digital Dental Laboratories, DBA OrthodentOshawa Ontario, CanadaManufacturer0000api.fda.gov
Edental Lab Co., LtdShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Exceldent Dental Technology Development Co., Ltd.Zhuhai Guangdong, ChinaManufacturer0000api.fda.gov
F-Six Dental Technology Co.,limitedCentral Hong Kong, Hong KongExporter to the US, Manufacturer0000api.fda.gov
Fseven Dental Technology Zhuhai Co.,ltdZHUHAI Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hexa Ceram Co., Ltd.Sansai Chiang Mai, ThailandManufacturer0000api.fda.gov
Jiyi Dental LaboratoryChanghua, TaiwanContract manufacturer0000api.fda.gov
Joydenta Dental LaboratoryShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Kamal Encon Industries LimitedFaridabad Haryana, IndiaManufacturer0000api.fda.gov
KTJ Dental Lab IncLos Angeles, CA, United StatesManufacturer for export0000api.fda.gov
KTJ Medical Technology Co.,Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Laboratorios Dentales De Zona Franca, S.A.Cartago, Costa RicaManufacturer0000api.fda.gov
Laxmi Dental Lab Usa Inc.Kenilworth, NJ, United StatesManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
League Dental Technology LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Libral Traders Pvt. Ltd.New Delhi, IndiaManufacturer0000api.fda.gov
Laxmi Dental LimitedPalghar Maharashtra, IndiaManufacturer0000api.fda.gov
M/S Leixir Resources Pvt. LtdGURUGRAM Haryana, IndiaManufacturer0000api.fda.gov
Modern Dental Laboratory (DG) Co., Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
Nam A Dental Medicine Company LimitedThong Tay Hoi Ward Ho Chi Minh, VietnamManufacturer0000api.fda.gov
One Day Dental PartnerSuncheon-si Jeonnam, South KoreaExporter to the US, Manufacturer0000api.fda.gov
Royal Dental LabShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shen Fu Arts LabShen Zhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen HLD Dental&technology Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Jinyi Medical Technology Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Times Dental LabShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shimmer Computerized Dental Technology Co.,ltdZhuhai Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Smile Dental Laboratory Company LimitedZhuhai Guangdong, ChinaManufacturer0000api.fda.gov
Smile Stones Dental Pvt LtdMADURAI Tamil Nadu, IndiaManufacturer0000api.fda.gov
Sun Dental Laboratories LLCSaint Petersburg, FL, United StatesSpecification developer0000api.fda.gov
Thanh Dental Laboratoryho chi minh city, VietnamContract manufacturer0000api.fda.gov
Tin Lok (Dongguan) Dental Laboratory Company LimitedDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Veden Dental Labs IncZhuhai Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Vico Dental Technology Co. LtdDongGuan City Guangdong, ChinaManufacturer0000api.fda.gov
ZH Graceful Dental Lab Co., Ltd.Zhuhai Guangdong, ChinaManufacturer0000api.fda.gov
Zhuhai Crystal Dental Technology Co.,ltdZhuhai Guangdong, ChinaManufacturer0000api.fda.gov
Zhuhai MJ Dental LaboratoryZhuhai Guangdong, ChinaManufacturer0000api.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.