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Data / Medical devices / Aligner, Sequential / United States

FDA-registered makers of Aligner, Sequential in the United States: 42 establishments

42 establishments in the United States are registered with the FDA to make Aligner, Sequential (product code NXC). 35 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Aligner, Sequential
Product code
NXC
Country
United States

Makers of Aligner, Sequential in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Align Technology, Inc.San Jose, CA, United StatesComplaint file establishment, Manufacturer, Specification developer10October 23, 2025000api.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
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
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
uLab Systems, IncMemphis, TN, United StatesManufacturer2February 24, 2022000api.fda.gov
3D Diagnostix IncAllston, MA, United StatesManufacturer1December 22, 2020000api.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
Allesee Orthodontic Appliances, Inc.Sturtevant, WI, United StatesComplaint file establishment, Manufacturer, Specification developer1June 18, 2004000api.fda.gov
BRIUS Technologies Inc.Carrollton, TX, United StatesManufacturer1January 22, 2021000api.fda.gov
Creodent Hudson ValleyFishkill, NY, United StatesManufacturer1October 13, 2022000api.fda.gov
Drake Precision Dental Laboratory, Inc.Charlotte, NC, United StatesManufacturer, Specification developer1November 9, 2020000api.fda.gov
Five Star Orthodontic Laboratory & Supply, Inc.Denton, TX, United StatesManufacturer1June 19, 2019000api.fda.gov
Great Lakes Dental Technologies, Ltd.Tonawanda, NY, United StatesManufacturer1June 1, 2018000api.fda.gov
Johns Dental LaboratoryTerre Haute, IN, United StatesManufacturer1February 9, 2022000api.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
Sun Dental Laboratories LLCSaint Petersburg, FL, United StatesSpecification developer1December 16, 2019000api.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 USA LLCCarrollton, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1June 2, 2021000api.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
Burbank Dental LaboratoryBurbank, CA, United StatesContract manufacturer0000api.fda.gov
Dentsply Sirona Orthodontics Inc.Sarasota, FL, United StatesManufacturer, Specification developer0000api.fda.gov
GC America Inc.Alsip, IL, United StatesContract manufacturer0000api.fda.gov
K Line FloridaWest Palm Beach, FL, United StatesContract manufacturer0000api.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.