Data / Medical devices / Implant, Endosseous, Orthodontic / United States
FDA-registered makers of Implant, Endosseous, Orthodontic in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Implant, Endosseous, Orthodontic (product code OAT). 8 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Implant, Endosseous, Orthodontic
- Product code
- OAT
- Country
- United States
Makers of Implant, Endosseous, Orthodontic in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 2 | December 16, 2010 | 0 | 0 | 0 | api.fda.gov |
| Biomet Microfixation | Jacksonville, FL, United States | Manufacturer | 1 | February 9, 2007 | 0 | 0 | 0 | api.fda.gov |
| Blue Sky Bio, LLC | Libertyville, IL, United States | Specification developer | 1 | December 17, 2020 | 0 | 0 | 0 | api.fda.gov |
| Eminent Spine, LLC | Plano, TX, United States | Manufacturer | 1 | December 17, 2020 | 0 | 0 | 0 | api.fda.gov |
| Ormco Corporation | Pomona, CA, United States | Complaint file establishment, Manufacturer | 1 | August 3, 2006 | 0 | 0 | 0 | api.fda.gov |
| Ormco Corporation | Brea, CA, United States | Complaint file establishment, Manufacturer | 1 | August 3, 2006 | 0 | 0 | 0 | api.fda.gov |
| Palaxa Precision LLC | Newport, MN, United States | Specification developer | 1 | April 28, 2022 | 0 | 0 | 0 | api.fda.gov |
| Zentek Medical LLC | Manalapan, NJ, United States | Specification developer | 1 | October 3, 2012 | 0 | 0 | 0 | api.fda.gov |
| Accumedix, Inc. | Libertyville, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eptam West LLC | Colorado Springs, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Elmira) | Horseheads, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Monument) | Monument, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Superior Machined Products, Inc. | Oceanside, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.