Data / Medical devices / United States / TMJ Services LLC
TMJ Services LLC: FDA-registered device maker in Franklin, TN, United States, 1 510(k) clearance
TMJ Services LLC is registered with the FDA (registration 3025434480) in Franklin, TN, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 25, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025434480
- Address
- 206 Gothic Ct, Suite 303, Franklin, TN, United States, 37067
- Owner or operator
- TMJ Services LLC (10086653)
- Roles
- Manufacturer
- First device listed
- November 29, 2022
- Registered through
- 2026
- Brand names listed
- Urbanek Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mouthguard, Migraine/Tension Headache | OCO | U | Manufacturer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 25, 2017 | K170985 | Urbanek Device | MQC | Substantially Equivalent | Tmj Services, LLC | accessdata.fda.gov |
Compare with other makers
Updated September 25, 2017. 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.