510(k) Report

FDA applicant

Jeneric/Pentron, Inc.

Wallingford, CT78 decisions1988–20024 recalls

FDA records 78 decisions for Jeneric/Pentron, Inc. (Wallingford, CT) from 1988 to 2002: 78 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EJT (Alloy, Gold-Based Noble Metal). Its devices cite 12 predicates, 9 of them its own earlier devices. 4 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 Jeneric/Pentron, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Jeneric/Pentron, Inc. since 2007.

Recalls per year

1in 2011

2009: 12010: 22011: 1
2007high 2 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Other applicant names beginning “Jeneric/Pentron”

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