FDA applicant

Pentron Clinical

Orange, CA4 decisions2011–20130 recalls

FDA records 4 decisions for Pentron Clinical (Orange, CA) from 2011 to 2013: 4 510(k) clearances. Most are in product codes ELW (Material, Impression) and EBF (Material, Tooth Shade, Resin). Its devices cite 9 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 Pentron Clinical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2011high 2 (2011) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Pentron Clinical by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Pentron”

FDA records each applicant name separately; these may or may not be the same firm.

Pentron Corp. 15 Pentron Clinical Technologies 13 Pentron Laboratory Technologies 5 Pentron Ceramics, Inc. 2

Pentron Clinical

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?

Other applicant names beginning “Pentron”