510(k) Report

FDA applicant

International Profit Builders, Inc.

Highland, CA1 decision2014–20140 recalls

FDA records 1 decision for International Profit Builders, Inc. (Highland, CA) in 2014: 1 510(k) clearance. All are in product code OBR (Mouthguard, Over-The-Counter). Its devices cite 3 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 International Profit Builders, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — International Profit Builders, Inc. by year, 2014–2026Sources: 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 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K132469The Bite GuardInternational Profit Builders, Inc. · 2014

The one decision as International Profit Builders, Inc. →