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Data / Medical devices / Orthodontic Software

Orthodontic Software (PNN): 38 FDA-registered makers in 10 countries

38 establishments in 10 countries are registered with the FDA to make Orthodontic Software (product code PNN, Class 2, 21 CFR 872.5470). 26 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 37 510(k) clearances under this code, the latest on October 23, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

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Get every maker of this deviceMakers in the United StatesWatch this device
Product code
PNN
Device class
2
Regulation
872.5470
Medical specialty
Dental

Makers by country

CountryMakers
United States20
China5
Mexico3
South Korea3
Germany2
Denmark1
Spain1
Taiwan1
Poland1
Czechia1

Makers of Orthodontic Software

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
3Shape A/SCopenhagen Hovedstaden, DenmarkManufacturer4November 27, 2019000api.fda.gov
Software Nemotec, S.L.Leganes Madrid(Province), SpainManufacturer2November 21, 2023000api.fda.gov
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
Aligntech de Mexico S, de R. L. de C. V.Cd. Juarez Chihuahua, MexicoManufacturer1September 25, 2026000api.fda.gov
Aligntech de Mexico S, de R. L. de C. V.Cd. Juarez Chihuahua, MexicoManufacturer1September 25, 2026000api.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
Hangzhou Chohotech Co., LtdHangzhou Zhejiang, ChinaManufacturer1May 8, 2026000api.fda.gov
Inteware Co., LtdChiayi County Chiayi(County), TaiwanManufacturer1September 12, 2019000api.fda.gov
Laon Medi Inc.Gwacheon-si, Gyeonggi-do, South KoreaManufacturer1April 23, 2025000api.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
Ray Co., LtdYongin-si Gyeonggi, South KoreaManufacturer1May 16, 2024000api.fda.gov
Shanghai Ea Medical Instruments Co., Ltd.Yangpu District Shanghai, ChinaManufacturer1June 13, 2023000api.fda.gov
Sirona Dental Systems GMBHBENSHEIM Hesse, GermanyManufacturer1January 11, 2018000api.fda.gov
Softsmile, Inc.Long Island City, NY, United StatesSpecification developer1December 21, 2021000api.fda.gov
Align Technology AFAB Poland Sp. z o.o.Wroclaw Dolnoslaskie, PolandManufacturer0000api.fda.gov
Blue Sky Bio, LLCLibertyville, IL, United StatesSpecification developer0000api.fda.gov
EH Labs CZ s.r.o.Dvur Kralove nad Labem Hradec Kralove, CzechiaContract 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
Image Instruments GMBHChemnitz Saxony, GermanyManufacturer0000api.fda.gov
LightForce OrthodonticsWilmington, MA, United StatesManufacturer0000api.fda.gov
Medit Corp.Seoul, South KoreaContract manufacturer0000api.fda.gov
Ormco CorporationPomona, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Ormco CorporationBrea, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
SDS de Mexico S. de R.L. de C.V.MEXICALI, B.C. C.P. Baja California, MexicoContract manufacturer0000api.fda.gov

Updated October 23, 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.