FDA applicant
Pentron Corp.
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
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
Class I Class II/III not classified
Planning a device like Pentron Corp.’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 “Pentron”
FDA records each applicant name separately; these may or may not be the same firm.