510(k) Report

FDA applicant

Reazeal Corp

Wilmington, DE1 decision2023–20230 recalls

FDA records 1 decision for Reazeal Corp (Wilmington, DE) in 2023: 1 510(k) clearance. All are in product code OBR (Mouthguard, Over-The-Counter). Its devices cite 1 predicate, 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 Reazeal Corp’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Reazeal Corp by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OBRMouthguard, Over-The-Counter1decision

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K231865Mouth Guard (ATG0603R)Reazeal Corp · 20231cites it

What has FDA decided for it lately?

  • K231865Mouth Guard (ATG0603R)Reazeal Corp · 2023

The one decision as Reazeal Corp →