Data / Medical devices / Mouthguard, Migraine/Tension Headache / United States
FDA-registered makers of Mouthguard, Migraine/Tension Headache in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Mouthguard, Migraine/Tension Headache (product code OCO). 2 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
- Mouthguard, Migraine/Tension Headache
- Product code
- OCO
- Country
- United States
Makers of Mouthguard, Migraine/Tension Headache in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Boyd Research | St Pete Beach, FL, United States | Manufacturer | 1 | June 20, 2001 | 0 | 0 | 0 | api.fda.gov |
| Keller Laboratories | Fenton, MO, United States | Manufacturer | 1 | June 20, 2001 | 0 | 0 | 0 | api.fda.gov |
| 3DPX Medical | Chicago, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Grindguard Inc | San Francisco, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Myohealth Technologies, LLC | Portland, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Owl Dental | San Leandro, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remvia, LLC | Saint Louis, MO, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Serena Sleep | Hudson, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Slow Wave, Inc. | Lakeway, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TMJ Services LLC | Franklin, TN, United States | 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.