510(k) Report

FDA applicant

Pentron Corp.

Wallingford, CT15 decisions1984–20026 recalls

FDA records 15 decisions for Pentron Corp. (Wallingford, CT) from 1984 to 2002: 15 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and KLE (Agent, Tooth Bonding, Resin). Its devices cite 1 predicate, 0 of them its own earlier devices. 6 recalls are 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 Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pentron Corp. since 2007.

Recalls per year

5in 2011

2009: 12011: 5
2007high 5 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Pentron”

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