FDA applicant
Jeneric/Pentron, Inc.
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
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
Class I Class II/III not classified
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.
See the 510(k) ReportOther applicant names beginning “Jeneric/Pentron”
FDA records each applicant name separately; these may or may not be the same firm.