510(k) Report

FDA applicant

Pentron Clinical Technologies

Wallingford, CT13 decisions2002–200910 recalls

FDA records 13 decisions for Pentron Clinical Technologies (Wallingford, CT) from 2002 to 2009: 13 510(k) clearances. Most are in product codes EMA (Cement, Dental) and EBF (Material, Tooth Shade, Resin). Its devices cite 7 predicates, 0 of them its own earlier devices. 10 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 Clinical Technologies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 42008: 12009: 1
2007high 4 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

3in 2011

2009: 12010: 62011: 3
2007high 6 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Pentron Clinical Technologies 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.