Data / Medical devices / Mouthguard, Migraine/Tension Headache
Mouthguard, Migraine/Tension Headache (OCO): 11 FDA-registered makers in 2 countries
11 establishments in 2 countries are registered with the FDA to make Mouthguard, Migraine/Tension Headache (product code OCO, Class U). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on June 24, 2021, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OCO
- Device class
- U
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Canada | 1 |
Makers of Mouthguard, Migraine/Tension Headache
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 |
|---|---|---|---|---|---|---|---|---|
| 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 | |
| Panthera Dental Inc | Quebec City, Canada | Complaint file establishment, 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 June 24, 2021. 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.