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Data / Medical devices / Orthodontic Software / United States

FDA-registered makers of Orthodontic Software in the United States: 20 establishments

20 establishments in the United States are registered with the FDA to make Orthodontic Software (product code PNN). 16 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

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Device
Orthodontic Software
Product code
PNN
Country
United States

Makers of Orthodontic Software in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
uLab Systems, IncMemphis, TN, United StatesManufacturer2June 23, 2020000api.fda.gov
Archform, Inc.Santa Clara, CA, United StatesManufacturer1December 16, 2021000api.fda.gov
Align Technology, Inc.San Jose, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1September 25, 2026010api.fda.gov
BRIUS Technologies Inc.Carrollton, TX, United StatesManufacturer1April 17, 2020000api.fda.gov
CDB CorporationLeland, NC, United StatesComplaint file establishment, Specification developer1January 25, 2022000api.fda.gov
Clearadvance, LLCIrvine, CA, United StatesManufacturer1October 13, 2023000api.fda.gov
CelebraceColleyville, TX, United StatesManufacturer1December 29, 2025000api.fda.gov
Dental Imaging Technologies CorporationQuakertown, PA, United StatesComplaint file establishment, Manufacturer1April 2, 2020000api.fda.gov
Dentsply Sirona Orthodontics Inc.Richardson, TX, United StatesSpecification developer1March 4, 2026000api.fda.gov
Guidemia Technologies, LLCBuena Park, CA, United StatesManufacturer1March 24, 2017000api.fda.gov
Lorelli Technologies LLCFountain Valley, CA, United StatesManufacturer1February 19, 2021000api.fda.gov
OrthoselectAmerican Fork, UT, United StatesManufacturer1April 21, 2020000api.fda.gov
Park Dental Research CorpArdmore, OK, United StatesManufacturer1November 26, 2018000api.fda.gov
Progressive AlignersAliso Viejo, CA, United StatesSpecification developer1October 11, 2024000api.fda.gov
Progressive Orthodontics USAAliso Viejo, CA, United StatesRepackager or relabeler, Specification developer1October 11, 2024000api.fda.gov
Softsmile, Inc.Long Island City, NY, United StatesSpecification developer1December 21, 2021000api.fda.gov
Blue Sky Bio, LLCLibertyville, IL, United StatesSpecification developer0000api.fda.gov
LightForce OrthodonticsWilmington, MA, United StatesManufacturer0000api.fda.gov
Ormco CorporationPomona, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Ormco CorporationBrea, CA, United StatesComplaint file establishment, Specification developer0000api.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.