FDA applicant
Pre-Dent System
FDA records 3 decisions for Pre-Dent System (Mchenry, IL) in 1980: 3 510(k) clearances. All are in product code KSS (Supplies, Blood-Bank). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Pre-Dent System’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Pre-Dent System since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Pre-Dent System’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) Report