510(k) Report

FDA applicant

Doc Brands, Inc.

Wayne, PA2 decisions2022–20250 recalls

FDA records 2 decisions for Doc Brands, Inc. (Wayne, PA) from 2022 to 2025: 2 510(k) clearances. All are in product code OBR (Mouthguard, Over-The-Counter). 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 Doc Brands, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022: 12025: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Doc Brands, Inc. by year, 2022–2026Sources: 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-Counter2decisions

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K250456Dentemp Pro-Comfort Dental GuardDoc Brands, Inc. · 2025
  • K222424Protect-It Custom Fit Dental GuardDoc Brands, Inc. · 2022

All 2 as Doc Brands, Inc. →