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.
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- Product code
- DYT
- Device class
- 1
- Regulation
- 872.5525
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 24 |
| China | 19 |
| Mexico | 6 |
| Germany | 6 |
| India | 4 |
| Australia | 2 |
| South Korea | 2 |
| Brazil | 1 |
| Vietnam | 1 |
| Poland | 1 |
| Canada | 1 |
| Czechia | 1 |
| Costa Rica | 1 |
| Italy | 1 |
| Finland | 1 |
| Netherlands | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aditek Do Brasil, SA | CRAVINHOS Sao Paulo, Brazil | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| American Orthodontics | Sheboygan, WI, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Angelalign Manufacturing Corp. | Oak Creek, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Archform, Inc. | Santa Clara, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aceso Dental Laboratory Company Limited | An Phuoc Ward Dong Nai, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Align Technology AFAB Poland Sp. z o.o. | Wroclaw Dolnoslaskie, Poland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Align Technology, Inc. | San Jose, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aligntech de Mexico S, de R. L. de C. V. | Cd. Juarez Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aligntech de Mexico S, de R. L. de C. V. | Cd. Juarez Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allesee Orthodontic Appliances, Inc. | Sturtevant, WI, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Chuangnuo Medical equipment Co., LTD | Anqing City Anhui, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Border Assembly S. de R.L de C.V. | Tijuana Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chewly Pty. Ltd. | Bellfield Victoria, Australia | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dantech Digital Dental Solutions Private Limited | Chennai Tamil Nadu, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deltamed GMBH | FRIEDBERG Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentona AG | Dortmund North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Detax GMBH | ETTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DMG Digital Enterprises Se | Hamburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Gooodol Mould & Product Co.,ltd | DongGuan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentaurum GmbH & Co. KG | ISPRINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digital Dental Laboratories, DBA Orthodent | Oshawa Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| E. Tec SA De C.V. | Tijuana Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EH Labs CZ s.r.o. | Dvur Kralove nad Labem Hradec Kralove, Czechia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eoca MD Pty Limited | Double Bay New South Wales, Australia | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Envista (Sichuan) Medical Device Co., Ltd. | Ziyang Sichuan, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Envista (Suzhou) Medical Device Co., Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Envista (Suzhou) Medical Device Co., Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Five Star Orthodontic Laboratory & Supply, Inc. | Denton, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Formlabs Inc. | Somerville, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Formlabs Ohio, Inc. | Millbury, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GC America Inc. | Alsip, IL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GC Orthodontics America Inc. | Alsip, IL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| GNI Co., LTD | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Good Sleep Co Usa LLC | Grand Prairie, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Wise Medical Device Co.,ltd | Hangzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huanghua Promisee Dental Co., Ltd | Huanghua Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hype Align Clear Orthodontics, Limitada | Santa Ana San Jose, Costa Rica | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J C India | Rajkot Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Joydenta Dental Laboratory | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kids-E-Dental LLP | Mumbai Maharashtra, India | Foreign private label distributor, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Libral Traders Pvt. Ltd. | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Luxcreo Inc. | Chicago, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modern Dental Laboratory (DG) Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nacs, Inc | Ham Lake, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Sezen Technology Co., Ltd. | Ningbo Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nusmile, Ltd | Houston, TX, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ods Co., Ltd. | Incheon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthguide Medical Technology (jiangsu) Co., Ltd | Wuxi City Jiangsu, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho Dental Lab, LLC | Antioch, TN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho Organizers, Inc. | Savannah, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthodontic Manufacturer Sia SRL | ROCCA D EVANDRO Caserta, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ormco Corporation | Pomona, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ormco Corporation | Brea, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho Solutions LC | Lake Saint Louis, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pac-Dent Inc. | Brea, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro3dure Medical GMBH | Iserlohn North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Park Dental Research Corp | Ardmore, OK, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SDS de Mexico S. de R.L. de C.V. | MEXICALI, B.C. C.P. Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Maxflex Medical Technology Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Bairunheng Technology Co., Ltd. | shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smylio | Fremont, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stick Tech Ltd. | TURKU Pirkanmaa, Finland | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Laixin 3D Technology Co.,ltd | Suzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sharp Detail Orthodontic Laboratory S DE EL DE CV | Tijuana Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Orthodontics Corporation | Monrovia, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Belport Company, Inc DBA Gingi-Pak | Camarillo, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vertex-Dental B.V. | Soesterberg Utrecht, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuxi Ea Medical Instruments Technologies Limited | Wuxi Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Longmed Medical Technology Co., Ltd. | Huzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Protect Medical Equipment Co. Ltd. | Anji Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.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.