FDA applicant

Pac-Dent International, Inc.

Brea, CA9 decisions2013–20170 recalls

FDA records 9 decisions for Pac-Dent International, Inc. (Brea, CA) from 2013 to 2017: 9 510(k) clearances. Most are in product codes KJJ (Cleanser, Root Canal) and EBC (Sealant, Pit And Fissure, And Conditioner). Its devices cite 11 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

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Pac-Dent International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2013high 3 (2015) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Pac-Dent International, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Pac-Dent International, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?