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Data / Medical devices / Maintainer, Space Preformed, Orthodontic / United States

FDA-registered makers of Maintainer, Space Preformed, Orthodontic in the United States: 24 establishments

24 establishments in the United States are registered with the FDA to make Maintainer, Space Preformed, Orthodontic (product code DYT). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.

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Device
Maintainer, Space Preformed, Orthodontic
Product code
DYT
Country
United States

Makers of Maintainer, Space Preformed, Orthodontic in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
American OrthodonticsSheboygan, WI, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Angelalign Manufacturing Corp.Oak Creek, WI, United StatesContract manufacturer0000api.fda.gov
Archform, Inc.Santa Clara, CA, United StatesManufacturer0000api.fda.gov
Align Technology, Inc.San Jose, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Allesee Orthodontic Appliances, Inc.Sturtevant, WI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Five Star Orthodontic Laboratory & Supply, Inc.Denton, TX, United StatesManufacturer0000api.fda.gov
Formlabs Inc.Somerville, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Formlabs Ohio, Inc.Millbury, OH, United StatesManufacturer0000api.fda.gov
GC America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
GC Orthodontics America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Good Sleep Co Usa LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
Luxcreo Inc.Chicago, IL, United StatesSpecification developer0000api.fda.gov
Nacs, IncHam Lake, MN, United StatesContract manufacturer0000api.fda.gov
Nusmile, LtdHouston, TX, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Ortho Dental Lab, LLCAntioch, TN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Ortho Organizers, Inc.Savannah, GA, United StatesSpecification developer0000api.fda.gov
Ormco CorporationPomona, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Ormco CorporationBrea, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ortho Solutions LCLake Saint Louis, MO, United StatesManufacturer0000api.fda.gov
Pac-Dent Inc.Brea, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Park Dental Research CorpArdmore, OK, United StatesManufacturer0000api.fda.gov
SmylioFremont, CA, United StatesManufacturer0000api.fda.gov
Solventum Orthodontics CorporationMonrovia, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
The Belport Company, Inc DBA Gingi-PakCamarillo, CA, United StatesManufacturer0000api.fda.gov

Updated November 3, 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.