Data / Medical devices / Aligner, Sequential
Aligner, Sequential (NXC): 85 FDA-registered makers in 19 countries
85 establishments in 19 countries are registered with the FDA to make Aligner, Sequential (product code NXC, Class 2, 21 CFR 872.5470). 64 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 145 510(k) clearances under this code, the latest on July 2, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NXC
- Device class
- 2
- Regulation
- 872.5470
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 42 |
| China | 15 |
| Mexico | 6 |
| South Korea | 4 |
| Pakistan | 2 |
| Germany | 2 |
| Brazil | 2 |
| Philippines | 1 |
| Poland | 1 |
| France | 1 |
| Jordan | 1 |
| Italy | 1 |
| Portugal | 1 |
| India | 1 |
| Taiwan | 1 |
| Spain | 1 |
| Costa Rica | 1 |
| Czechia | 1 |
| Egypt | 1 |
Makers of Aligner, Sequential
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 |
|---|---|---|---|---|---|---|---|---|
| Align Technology, Inc. | San Jose, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 10 | October 23, 2025 | 0 | 0 | 0 | api.fda.gov |
| Aligntech de Mexico S, de R. L. de C. V. | Cd. Juarez Chihuahua, Mexico | Manufacturer | 10 | October 23, 2025 | 0 | 0 | 0 | api.fda.gov |
| Aligntech de Mexico S, de R. L. de C. V. | Cd. Juarez Chihuahua, Mexico | Manufacturer | 9 | October 23, 2025 | 0 | 0 | 0 | api.fda.gov |
| Clearpath Orthodontics | Lahore Punjab, Pakistan | Exporter to the US, Manufacturer | 3 | January 5, 2021 | 0 | 0 | 0 | api.fda.gov |
| Ormco Corporation | Pomona, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | February 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ormco Corporation | Brea, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | February 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Solventum Orthodontics Corporation | Monrovia, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | September 29, 2023 | 0 | 0 | 0 | api.fda.gov |
| Wuxi Ea Medical Instruments Technologies Limited | Wuxi Jiangsu, China | Exporter to the US, Manufacturer | 3 | June 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Blue Sky Bio, LLC | Libertyville, IL, United States | Specification developer | 2 | February 24, 2023 | 0 | 0 | 0 | api.fda.gov |
| CDB Corporation | Leland, NC, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | June 4, 2021 | 0 | 0 | 0 | api.fda.gov |
| ClearCorrect, LLC | Round Rock, TX, United States | Manufacturer | 2 | August 6, 2021 | 0 | 0 | 0 | api.fda.gov |
| Dentsply Sirona Orthodontics Inc. | Richardson, TX, United States | Specification developer | 2 | April 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Luxcreo Inc. | Chicago, IL, United States | Manufacturer, Specification developer | 2 | April 8, 2025 | 0 | 0 | 0 | api.fda.gov |
| Modern Dental Laboratory (DG) Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 2 | September 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| New England Orthodontic Laboratory | Andover, MA, United States | Manufacturer, Specification developer | 2 | January 6, 2021 | 0 | 0 | 0 | api.fda.gov |
| Ortho Dental Lab, LLC | Antioch, TN, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 2 | March 16, 2022 | 0 | 0 | 0 | api.fda.gov |
| Park Dental Research Corp | Ardmore, OK, United States | Contract manufacturer, Manufacturer | 2 | April 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| Smylio | Fremont, CA, United States | Manufacturer | 2 | April 5, 2023 | 0 | 0 | 0 | api.fda.gov |
| Specialty Appliances, LLC | Cumming, GA, United States | Manufacturer | 2 | January 3, 2019 | 0 | 0 | 0 | api.fda.gov |
| TNS Co.,ltd | Geumcheon-gu, Seoul, South Korea | Complaint file establishment, Manufacturer, Repackager or relabeler | 2 | September 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Yinchili Medical Technology Co.,ltd | Jiaxing City Zhejiang, China | Contract manufacturer, Manufacturer | 2 | April 17, 2023 | 0 | 0 | 0 | api.fda.gov |
| uLab Systems, Inc | Memphis, TN, United States | Manufacturer | 2 | February 24, 2022 | 0 | 0 | 0 | api.fda.gov |
| 3D Diagnostix Inc | Allston, MA, United States | Manufacturer | 1 | December 22, 2020 | 0 | 0 | 0 | api.fda.gov |
| Aidite (qinhuangdao) Technology Co., Ltd | Qinhuangdao City Hebei, China | Manufacturer | 1 | August 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| Alien Milling Technologies | Glendora, CA, United States | Manufacturer | 1 | July 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Alta Smiles, LLC | Fort Washington, PA, United States | Manufacturer | 1 | June 2, 2021 | 0 | 0 | 0 | api.fda.gov |
| Archform, Inc. | Santa Clara, CA, United States | Manufacturer | 1 | March 11, 2016 | 0 | 0 | 0 | api.fda.gov |
| Aso International Manila, Inc. | Cavite,Region IVa,, Philippines | Manufacturer | 1 | February 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Align Technology AFAB Poland Sp. z o.o. | Wroclaw Dolnoslaskie, Poland | Manufacturer | 1 | June 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Allesee Orthodontic Appliances, Inc. | Sturtevant, WI, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | June 18, 2004 | 0 | 0 | 0 | api.fda.gov |
| Beame Medical Technology (shenzhen) Limited | Shenzhen Guangdong, China | Manufacturer | 1 | January 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| BRIUS Technologies Inc. | Carrollton, TX, United States | Manufacturer | 1 | January 22, 2021 | 0 | 0 | 0 | api.fda.gov |
| Biotech Dental Smilers, SAS | Salon-de-Provence Bouches-du-Rhone, France | Manufacturer | 1 | September 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Border Assembly S. de R.L de C.V. | Tijuana Baja California, Mexico | Contract manufacturer, Manufacturer | 1 | May 9, 2019 | 0 | 0 | 0 | api.fda.gov |
| Clearmoves Aligners | Lahore Punjab, Pakistan | Manufacturer | 1 | August 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| Creodent Hudson Valley | Fishkill, NY, United States | Manufacturer | 1 | October 13, 2022 | 0 | 0 | 0 | api.fda.gov |
| Cristaline Aligners GMBH | Pforzheim Baden-Wurttemberg, Germany | Manufacturer | 1 | December 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Dentis Co., Ltd. | Daegu, South Korea | Manufacturer | 1 | February 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Drake Precision Dental Laboratory, Inc. | Charlotte, NC, United States | Manufacturer, Specification developer | 1 | November 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| Dreve Dentamid GMBH | UNNA North Rhine-Westphalia, Germany | Manufacturer | 1 | November 7, 2025 | 0 | 0 | 0 | api.fda.gov |
| Eon Dental Jordan (Free Zones) | Amman Al 'Asimah, Jordan | Contract manufacturer, Manufacturer | 1 | September 28, 2020 | 0 | 0 | 0 | api.fda.gov |
| Five Star Orthodontic Laboratory & Supply, Inc. | Denton, TX, United States | Manufacturer | 1 | June 19, 2019 | 0 | 0 | 0 | api.fda.gov |
| Geo S.R.L. | San Cesareo Roma, Italy | Manufacturer | 1 | October 7, 2022 | 0 | 0 | 0 | api.fda.gov |
| Graphy Inc. | Seoul, South Korea | Exporter to the US, Manufacturer | 1 | March 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| Great Lakes Dental Technologies, Ltd. | Tonawanda, NY, United States | Manufacturer | 1 | June 1, 2018 | 0 | 0 | 0 | api.fda.gov |
| JJGC Industria e Comercio de Materiais Dentarios SA | Curitiba Parana, Brazil | Contract manufacturer, Manufacturer | 1 | August 6, 2021 | 0 | 0 | 0 | api.fda.gov |
| Johns Dental Laboratory | Terre Haute, IN, United States | Manufacturer | 1 | February 9, 2022 | 0 | 0 | 0 | api.fda.gov |
| K Line Portugal Unipessoal Ltd | Chaves Braga, Portugal | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | 1 | March 16, 2022 | 0 | 0 | 0 | api.fda.gov |
| Laxmi Dental Limited | Palghar Maharashtra, India | Exporter to the US, Manufacturer, Remanufacturer | 1 | April 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Mem Dental Technology Co Ltd | Tainan, Taiwan | Manufacturer | 1 | May 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ods Co., Ltd. | Incheon, South Korea | Manufacturer | 1 | July 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ohlendorf Company | Affton, MO, United States | Manufacturer | 1 | May 19, 2021 | 0 | 0 | 0 | api.fda.gov |
| Ortho Solutions LC | Lake Saint Louis, MO, United States | Manufacturer | 1 | June 27, 2019 | 0 | 0 | 0 | api.fda.gov |
| Reliance Orthodontic Products, Inc. | Itasca, IL, United States | Repackager or relabeler, Specification developer | 1 | April 5, 2013 | 0 | 0 | 0 | api.fda.gov |
| Royal Dental Lab | Shenzhen Guangdong, China | Manufacturer | 1 | January 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| Sun Dental Laboratories LLC | Saint Petersburg, FL, United States | Specification developer | 1 | December 16, 2019 | 0 | 0 | 0 | api.fda.gov |
| Shandong Huge Dental Material Corporation | Rizhao Shandong, China | Manufacturer | 1 | April 18, 2019 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | August 16, 2022 | 0 | 0 | 0 | api.fda.gov |
| TP Orthodontics, Inc. | La Porte, IN, United States | Manufacturer | 1 | November 12, 2020 | 0 | 0 | 0 | api.fda.gov |
| The Argen Corporation | San Diego, CA, United States | Contract manufacturer, Manufacturer | 1 | June 7, 2019 | 0 | 0 | 0 | api.fda.gov |
| Utah Medical Products And Services | Murray, UT, United States | Manufacturer | 1 | February 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Vitang Technology LLC | Irvine, CA, United States | Manufacturer | 1 | January 29, 2020 | 0 | 0 | 0 | api.fda.gov |
| Xplora 3D Europe SL | Madrid Madrid(Province), Spain | Contract manufacturer, Manufacturer | 1 | December 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Xplora USA LLC | Carrollton, TX, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 1 | June 2, 2021 | 0 | 0 | 0 | api.fda.gov |
| Aditek Do Brasil, SA | CRAVINHOS Sao Paulo, Brazil | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Angelalign Manufacturing Corp. | Oak Creek, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bisco, Inc. | Schaumburg, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brasseler U.S.A. Dental, LLC | Savannah, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Border Assembly S. de R.L de C.V. | Tijuana B.C. Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Burbank Dental Laboratory | Burbank, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply Sirona Orthodontics Inc. | Sarasota, FL, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EH Dental Services Costa Rica Sociedad de Responsabilidad Limitada | Escazu, San Rafael San Jose, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EH Labs CZ s.r.o. | Dvur Kralove nad Labem Hradec Kralove, Czechia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Exceldent Dental Technology Development Co., Ltd. | Zhuhai Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Envista (Sichuan) Medical Device Co., Ltd. | Ziyang Sichuan, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Envista (Suzhou) Medical Device Co., Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Envista (Suzhou) Medical Device Co., Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GC America Inc. | Alsip, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| K Line Egypt | Cairo, Egypt | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| K Line Florida | West Palm Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Sezen Technology Co., Ltd. | Ningbo Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthodental S.A. de C.V. | Mexicali Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SDS de Mexico S. de R.L. de C.V. | MEXICALI, B.C. C.P. Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sichuan Yinli Medical Equipment Co., Ltd | Ziyang City Sichuan, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xi'an Henghui Technology, Ltd | Xi'an Shaanxi, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 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.