FDA applicant
Lee Pharmaceuticals
FDA records 29 decisions for Lee Pharmaceuticals (Mchenry, IL) from 1976 to 1993: 29 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and KLE (Agent, Tooth Bonding, Resin). 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 Lee Pharmaceuticals’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Lee Pharmaceuticals since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Lee Pharmaceuticals’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