510(k) Report

FDA applicant

Tmj Services, LLC

Franklin, TN1 decision2017–20170 recalls

FDA records 1 decision for Tmj Services, LLC (Franklin, TN) in 2017: 1 510(k) clearance. All are in product code MQC (Mouthguard, Prescription). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Tmj Services, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Tmj Services, LLC by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MQCMouthguard, Prescription1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K170985Urbanek DeviceTmj Services, LLC · 20171cites it

What has FDA decided for it lately?

  • K170985Urbanek DeviceTmj Services, LLC · 2017

The one decision as Tmj Services, LLC →