510(k) Report

FDA applicant

Pentron Ceramics, Inc.

Somerset, NJ2 decisions2007–20080 recalls

FDA records 2 decisions for Pentron Ceramics, Inc. (Somerset, NJ) from 2007 to 2008: 2 510(k) clearances. All are in product code EIH (Powder, Porcelain). 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

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

How often FDA has decided Pentron Ceramics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pentron Ceramics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pentron Ceramics, Inc.’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.