510(k) Report

FDA applicant

Grind Guard Technologies, LLC

Leola, PA2 decisions2009–20140 recalls

FDA records 2 decisions for Grind Guard Technologies, LLC (Leola, PA) from 2009 to 2014: 2 510(k) clearances. Most are in product codes OBR (Mouthguard, Over-The-Counter) and MQC (Mouthguard, Prescription). Its devices cite 6 predicates, 1 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 Grind Guard Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2009: 12014: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Grind Guard Technologies, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Grind Guard Technologies, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • OBRMouthguard, Over-The-Counter1decision
  • MQCMouthguard, Prescription1decision

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K082723GrindguardGrind Guard Technologies, LLC · 20092cite it
  • K133037GrindguardGrind Guard Technologies, LLC · 20141cites it

What has FDA decided for it lately?

  • K133037GrindguardGrind Guard Technologies, LLC · 2014
  • K082723GrindguardGrind Guard Technologies, LLC · 2009

All 2 as Grind Guard Technologies, LLC →