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Data / Medical devices / Maintainer, Space Preformed, Orthodontic

Maintainer, Space Preformed, Orthodontic (DYT): 72 FDA-registered makers in 16 countries

72 establishments in 16 countries are registered with the FDA to make Maintainer, Space Preformed, Orthodontic (product code DYT, Class 1, 21 CFR 872.5525). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on April 28, 1994, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
DYT
Device class
1
Regulation
872.5525
Medical specialty
Dental

Makers by country

CountryMakers
United States24
China19
Mexico6
Germany6
India4
Australia2
South Korea2
Brazil1
Vietnam1
Poland1
Canada1
Czechia1
Costa Rica1
Italy1
Finland1
Netherlands1

Makers of Maintainer, Space Preformed, Orthodontic

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
Aditek Do Brasil, SACRAVINHOS Sao Paulo, BrazilContract manufacturer0000api.fda.gov
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
Aceso Dental Laboratory Company LimitedAn Phuoc Ward Dong Nai, VietnamManufacturer0000api.fda.gov
Align Technology AFAB Poland Sp. z o.o.Wroclaw Dolnoslaskie, PolandManufacturer0000api.fda.gov
Align Technology, Inc.San Jose, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Aligntech de Mexico S, de R. L. de C. V.Cd. Juarez Chihuahua, MexicoManufacturer0000api.fda.gov
Aligntech de Mexico S, de R. L. de C. V.Cd. Juarez Chihuahua, MexicoManufacturer0000api.fda.gov
Allesee Orthodontic Appliances, Inc.Sturtevant, WI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Anhui Chuangnuo Medical equipment Co., LTDAnqing City Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Border Assembly S. de R.L de C.V.Tijuana Baja California, MexicoManufacturer0000api.fda.gov
Chewly Pty. Ltd.Bellfield Victoria, AustraliaSpecification developer0000api.fda.gov
Dantech Digital Dental Solutions Private LimitedChennai Tamil Nadu, IndiaManufacturer0000api.fda.gov
Deltamed GMBHFRIEDBERG Hesse, GermanyManufacturer0000api.fda.gov
Dentona AGDortmund North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Detax GMBHETTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
DMG Digital Enterprises SeHamburg, GermanyManufacturer0000api.fda.gov
Dongguan Gooodol Mould & Product Co.,ltdDongGuan City Guangdong, ChinaContract manufacturer0000api.fda.gov
Dentaurum GmbH & Co. KGISPRINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Digital Dental Laboratories, DBA OrthodentOshawa Ontario, CanadaManufacturer0000api.fda.gov
E. Tec SA De C.V.Tijuana Baja California, MexicoManufacturer0000api.fda.gov
EH Labs CZ s.r.o.Dvur Kralove nad Labem Hradec Kralove, CzechiaContract manufacturer0000api.fda.gov
Eoca MD Pty LimitedDouble Bay New South Wales, AustraliaSpecification developer0000api.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
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
GNI Co., LTDHwaseong-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Good Sleep Co Usa LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
Hangzhou Westlake Biomaterial Co., Ltd.Hangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hangzhou Wise Medical Device Co.,ltdHangzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Huanghua Promisee Dental Co., LtdHuanghua Hebei, ChinaManufacturer0000api.fda.gov
Hype Align Clear Orthodontics, LimitadaSanta Ana San Jose, Costa RicaContract manufacturer, Manufacturer0000api.fda.gov
J C IndiaRajkot Gujarat, IndiaManufacturer0000api.fda.gov
Joydenta Dental LaboratoryShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Kids-E-Dental LLPMumbai Maharashtra, IndiaForeign private label distributor, Manufacturer, Specification developer0000api.fda.gov
Libral Traders Pvt. Ltd.New Delhi, IndiaManufacturer0000api.fda.gov
Luxcreo Inc.Chicago, IL, United StatesSpecification developer0000api.fda.gov
Modern Dental Laboratory (DG) Co., Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
Nacs, IncHam Lake, MN, United StatesContract manufacturer0000api.fda.gov
Ningbo Sezen Technology Co., Ltd.Ningbo Zhejiang, ChinaContract manufacturer0000api.fda.gov
Nusmile, LtdHouston, TX, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Ods Co., Ltd.Incheon, South KoreaManufacturer0000api.fda.gov
Orthguide Medical Technology (jiangsu) Co., LtdWuxi City Jiangsu, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Ortho Dental Lab, LLCAntioch, TN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Ortho Organizers, Inc.Savannah, GA, United StatesSpecification developer0000api.fda.gov
Orthodontic Manufacturer Sia SRLROCCA D EVANDRO Caserta, ItalyManufacturer0000api.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
Pro3dure Medical GMBHIserlohn North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Park Dental Research CorpArdmore, OK, United StatesManufacturer0000api.fda.gov
SDS de Mexico S. de R.L. de C.V.MEXICALI, B.C. C.P. Baja California, MexicoContract manufacturer0000api.fda.gov
Shanghai Maxflex Medical Technology Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shenzhen Bairunheng Technology Co., Ltd.shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
SmylioFremont, CA, United StatesManufacturer0000api.fda.gov
Stick Tech Ltd.TURKU Pirkanmaa, FinlandComplaint file establishment, Manufacturer0000api.fda.gov
Suzhou Laixin 3D Technology Co.,ltdSuzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Sharp Detail Orthodontic Laboratory S DE EL DE CVTijuana Baja California, MexicoManufacturer0000api.fda.gov
Shenzhen Sunmc Dental Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.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
Vertex-Dental B.V.Soesterberg Utrecht, NetherlandsManufacturer0000api.fda.gov
Wuxi Ea Medical Instruments Technologies LimitedWuxi Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhejiang Longmed Medical Technology Co., Ltd.Huzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Protect Medical Equipment Co. Ltd.Anji Zhejiang, ChinaManufacturer0000api.fda.gov

Updated April 28, 1994. 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.