FDA applicant
Pentron Clinical Technologies
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
How often FDA has decided Pentron Clinical Technologies’s devices, and how often a recall has named them.
FDA decisions per year
1in 2009
2026 so far, outlined.
Recalls per year
3in 2011
Class I Class II/III not classified
Planning a device like Pentron Clinical Technologies’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.