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
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Allesee Orthodontic Appliances, Inc. | Sturtevant, WI, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | June 18, 2004 | 0 | 0 | 0 | api.fda.gov |
| BRIUS Technologies Inc. | Carrollton, TX, United States | Manufacturer | 1 | January 22, 2021 | 0 | 0 | 0 | api.fda.gov |
| Creodent Hudson Valley | Fishkill, NY, United States | Manufacturer | 1 | October 13, 2022 | 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 |
| Five Star Orthodontic Laboratory & Supply, Inc. | Denton, TX, United States | Manufacturer | 1 | June 19, 2019 | 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 |
| Johns Dental Laboratory | Terre Haute, IN, United States | Manufacturer | 1 | February 9, 2022 | 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 |
| Sun Dental Laboratories LLC | Saint Petersburg, FL, United States | Specification developer | 1 | December 16, 2019 | 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 USA LLC | Carrollton, TX, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 1 | June 2, 2021 | 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 | |
| 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 | |
| GC America Inc. | Alsip, IL, United States | 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 |
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.