Data / Medical devices / Bracket, Plastic, Orthodontic / United States
FDA-registered makers of Bracket, Plastic, Orthodontic in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Bracket, Plastic, Orthodontic (product code DYW). 9 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Bracket, Plastic, Orthodontic
- Product code
- DYW
- Country
- United States
Makers of Bracket, Plastic, Orthodontic in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ormco Corporation | Pomona, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 5 | March 26, 2013 | 0 | 0 | 0 | api.fda.gov |
| Ormco Corporation | Brea, CA, United States | Complaint file establishment, Specification developer | 5 | March 26, 2013 | 0 | 0 | 0 | api.fda.gov |
| Ortho Organizers, Inc. | Savannah, GA, United States | Manufacturer, Repackager or relabeler, Specification developer | 3 | November 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| American Orthodontics | Sheboygan, WI, United States | Manufacturer | 1 | March 31, 1989 | 0 | 0 | 0 | api.fda.gov |
| Blue Sky Bio, LLC | Libertyville, IL, United States | Specification developer | 1 | November 9, 2018 | 0 | 0 | 0 | api.fda.gov |
| CDB Corporation | Leland, NC, United States | Contract manufacturer, Manufacturer | 1 | November 21, 1997 | 0 | 0 | 0 | api.fda.gov |
| Great Lakes Dental Technologies, Ltd. | Tonawanda, NY, United States | Manufacturer | 1 | March 24, 2016 | 0 | 0 | 0 | api.fda.gov |
| Solventum Orthodontics Corporation | Monrovia, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | November 29, 1994 | 0 | 0 | 0 | api.fda.gov |
| Ultradent Products Inc. | South Jordan, UT, United States | Manufacturer | 1 | May 3, 2007 | 0 | 0 | 0 | api.fda.gov |
| Sun Dental Laboratories LLC | Saint Petersburg, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum US LLC | Irvine, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.