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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

CountryMakers
United States42
China15
Mexico6
South Korea4
Pakistan2
Germany2
Brazil2
Philippines1
Poland1
France1
Jordan1
Italy1
Portugal1
India1
Taiwan1
Spain1
Costa Rica1
Czechia1
Egypt1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Align Technology, Inc.San Jose, CA, United StatesComplaint file establishment, Manufacturer, Specification developer10October 23, 2025000api.fda.gov
Aligntech de Mexico S, de R. L. de C. V.Cd. Juarez Chihuahua, MexicoManufacturer10October 23, 2025000api.fda.gov
Aligntech de Mexico S, de R. L. de C. V.Cd. Juarez Chihuahua, MexicoManufacturer9October 23, 2025000api.fda.gov
Clearpath OrthodonticsLahore Punjab, PakistanExporter to the US, Manufacturer3January 5, 2021000api.fda.gov
Ormco CorporationPomona, CA, United StatesComplaint file establishment, Manufacturer, Specification developer3February 20, 2025000api.fda.gov
Ormco CorporationBrea, CA, United StatesComplaint file establishment, Manufacturer, Specification developer3February 20, 2025000api.fda.gov
Solventum Orthodontics CorporationMonrovia, CA, United StatesComplaint file establishment, Manufacturer, Specification developer3September 29, 2023000api.fda.gov
Wuxi Ea Medical Instruments Technologies LimitedWuxi Jiangsu, ChinaExporter to the US, Manufacturer3June 13, 2023000api.fda.gov
Blue Sky Bio, LLCLibertyville, IL, United StatesSpecification developer2February 24, 2023000api.fda.gov
CDB CorporationLeland, NC, United StatesComplaint file establishment, Manufacturer, Specification developer2June 4, 2021000api.fda.gov
ClearCorrect, LLCRound Rock, TX, United StatesManufacturer2August 6, 2021000api.fda.gov
Dentsply Sirona Orthodontics Inc.Richardson, TX, United StatesSpecification developer2April 15, 2026000api.fda.gov
Luxcreo Inc.Chicago, IL, United StatesManufacturer, Specification developer2April 8, 2025000api.fda.gov
Modern Dental Laboratory (DG) Co., Ltd.Dongguan Guangdong, ChinaManufacturer2September 1, 2023000api.fda.gov
New England Orthodontic LaboratoryAndover, MA, United StatesManufacturer, Specification developer2January 6, 2021000api.fda.gov
Ortho Dental Lab, LLCAntioch, TN, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler2March 16, 2022000api.fda.gov
Park Dental Research CorpArdmore, OK, United StatesContract manufacturer, Manufacturer2April 5, 2024000api.fda.gov
SmylioFremont, CA, United StatesManufacturer2April 5, 2023000api.fda.gov
Specialty Appliances, LLCCumming, GA, United StatesManufacturer2January 3, 2019000api.fda.gov
TNS Co.,ltdGeumcheon-gu, Seoul, South KoreaComplaint file establishment, Manufacturer, Repackager or relabeler2September 11, 2025000api.fda.gov
Zhejiang Yinchili Medical Technology Co.,ltdJiaxing City Zhejiang, ChinaContract manufacturer, Manufacturer2April 17, 2023000api.fda.gov
uLab Systems, IncMemphis, TN, United StatesManufacturer2February 24, 2022000api.fda.gov
3D Diagnostix IncAllston, MA, United StatesManufacturer1December 22, 2020000api.fda.gov
Aidite (qinhuangdao) Technology Co., LtdQinhuangdao City Hebei, ChinaManufacturer1August 27, 2025000api.fda.gov
Alien Milling TechnologiesGlendora, CA, United StatesManufacturer1July 26, 2024000api.fda.gov
Alta Smiles, LLCFort Washington, PA, United StatesManufacturer1June 2, 2021000api.fda.gov
Archform, Inc.Santa Clara, CA, United StatesManufacturer1March 11, 2016000api.fda.gov
Aso International Manila, Inc.Cavite,Region IVa,, PhilippinesManufacturer1February 26, 2021000api.fda.gov
Align Technology AFAB Poland Sp. z o.o.Wroclaw Dolnoslaskie, PolandManufacturer1June 18, 2024000api.fda.gov
Allesee Orthodontic Appliances, Inc.Sturtevant, WI, United StatesComplaint file establishment, Manufacturer, Specification developer1June 18, 2004000api.fda.gov
Beame Medical Technology (shenzhen) LimitedShenzhen Guangdong, ChinaManufacturer1January 7, 2026000api.fda.gov
BRIUS Technologies Inc.Carrollton, TX, United StatesManufacturer1January 22, 2021000api.fda.gov
Biotech Dental Smilers, SASSalon-de-Provence Bouches-du-Rhone, FranceManufacturer1September 20, 2021000api.fda.gov
Border Assembly S. de R.L de C.V.Tijuana Baja California, MexicoContract manufacturer, Manufacturer1May 9, 2019000api.fda.gov
Clearmoves AlignersLahore Punjab, PakistanManufacturer1August 1, 2024000api.fda.gov
Creodent Hudson ValleyFishkill, NY, United StatesManufacturer1October 13, 2022000api.fda.gov
Cristaline Aligners GMBHPforzheim Baden-Wurttemberg, GermanyManufacturer1December 19, 2024000api.fda.gov
Dentis Co., Ltd.Daegu, South KoreaManufacturer1February 22, 2024000api.fda.gov
Drake Precision Dental Laboratory, Inc.Charlotte, NC, United StatesManufacturer, Specification developer1November 9, 2020000api.fda.gov
Dreve Dentamid GMBHUNNA North Rhine-Westphalia, GermanyManufacturer1November 7, 2025000api.fda.gov
Eon Dental Jordan (Free Zones)Amman Al 'Asimah, JordanContract manufacturer, Manufacturer1September 28, 2020000api.fda.gov
Five Star Orthodontic Laboratory & Supply, Inc.Denton, TX, United StatesManufacturer1June 19, 2019000api.fda.gov
Geo S.R.L.San Cesareo Roma, ItalyManufacturer1October 7, 2022000api.fda.gov
Graphy Inc.Seoul, South KoreaExporter to the US, Manufacturer1March 5, 2024000api.fda.gov
Great Lakes Dental Technologies, Ltd.Tonawanda, NY, United StatesManufacturer1June 1, 2018000api.fda.gov
JJGC Industria e Comercio de Materiais Dentarios SACuritiba Parana, BrazilContract manufacturer, Manufacturer1August 6, 2021000api.fda.gov
Johns Dental LaboratoryTerre Haute, IN, United StatesManufacturer1February 9, 2022000api.fda.gov
K Line Portugal Unipessoal LtdChaves Braga, PortugalComplaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler1March 16, 2022000api.fda.gov
Laxmi Dental LimitedPalghar Maharashtra, IndiaExporter to the US, Manufacturer, Remanufacturer1April 26, 2021000api.fda.gov
Mem Dental Technology Co LtdTainan, TaiwanManufacturer1May 21, 2025000api.fda.gov
Ods Co., Ltd.Incheon, South KoreaManufacturer1July 22, 2025000api.fda.gov
Ohlendorf CompanyAffton, MO, United StatesManufacturer1May 19, 2021000api.fda.gov
Ortho Solutions LCLake Saint Louis, MO, United StatesManufacturer1June 27, 2019000api.fda.gov
Reliance Orthodontic Products, Inc.Itasca, IL, United StatesRepackager or relabeler, Specification developer1April 5, 2013000api.fda.gov
Royal Dental LabShenzhen Guangdong, ChinaManufacturer1January 8, 2020000api.fda.gov
Sun Dental Laboratories LLCSaint Petersburg, FL, United StatesSpecification developer1December 16, 2019000api.fda.gov
Shandong Huge Dental Material CorporationRizhao Shandong, ChinaManufacturer1April 18, 2019000api.fda.gov
Shenzhen Sunmc Dental Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer1August 16, 2022000api.fda.gov
TP Orthodontics, Inc.La Porte, IN, United StatesManufacturer1November 12, 2020000api.fda.gov
The Argen CorporationSan Diego, CA, United StatesContract manufacturer, Manufacturer1June 7, 2019000api.fda.gov
Utah Medical Products And ServicesMurray, UT, United StatesManufacturer1February 26, 2021000api.fda.gov
Vitang Technology LLCIrvine, CA, United StatesManufacturer1January 29, 2020000api.fda.gov
Xplora 3D Europe SLMadrid Madrid(Province), SpainContract manufacturer, Manufacturer1December 20, 2024000api.fda.gov
Xplora USA LLCCarrollton, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1June 2, 2021000api.fda.gov
Aditek Do Brasil, SACRAVINHOS Sao Paulo, BrazilContract manufacturer0000api.fda.gov
Angelalign Manufacturing Corp.Oak Creek, WI, United StatesContract manufacturer0000api.fda.gov
Bisco, Inc.Schaumburg, IL, United StatesContract manufacturer0000api.fda.gov
Brasseler U.S.A. Dental, LLCSavannah, GA, United StatesContract manufacturer0000api.fda.gov
Border Assembly S. de R.L de C.V.Tijuana B.C. Baja California, MexicoContract manufacturer0000api.fda.gov
Burbank Dental LaboratoryBurbank, CA, United StatesContract manufacturer0000api.fda.gov
Dentsply Sirona Orthodontics Inc.Sarasota, FL, United StatesManufacturer, Specification developer0000api.fda.gov
EH Dental Services Costa Rica Sociedad de Responsabilidad LimitadaEscazu, San Rafael San Jose, Costa RicaContract manufacturer0000api.fda.gov
EH Labs CZ s.r.o.Dvur Kralove nad Labem Hradec Kralove, CzechiaContract manufacturer0000api.fda.gov
Exceldent Dental Technology Development Co., Ltd.Zhuhai Guangdong, ChinaContract manufacturer0000api.fda.gov
Envista (Sichuan) Medical Device Co., Ltd.Ziyang Sichuan, ChinaContract manufacturer0000api.fda.gov
Envista (Suzhou) Medical Device Co., Ltd.Suzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Envista (Suzhou) Medical Device Co., Ltd.Suzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
GC America Inc.Alsip, IL, United StatesContract manufacturer0000api.fda.gov
K Line EgyptCairo, EgyptContract manufacturer0000api.fda.gov
K Line FloridaWest Palm Beach, FL, United StatesContract manufacturer0000api.fda.gov
Ningbo Sezen Technology Co., Ltd.Ningbo Zhejiang, ChinaContract manufacturer0000api.fda.gov
Orthodental S.A. de C.V.Mexicali Baja California, MexicoContract manufacturer0000api.fda.gov
SDS de Mexico S. de R.L. de C.V.MEXICALI, B.C. C.P. Baja California, MexicoContract manufacturer0000api.fda.gov
Sichuan Yinli Medical Equipment Co., LtdZiyang City Sichuan, ChinaContract manufacturer0000api.fda.gov
Xi'an Henghui Technology, LtdXi'an Shaanxi, ChinaContract manufacturer0000api.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.