FDA applicant
Unicep
FDA records 9 decisions for Unicep (Sandpoint, ID) in 1993: 9 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and ELL (Teeth, Porcelain). 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 Unicep’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Unicep since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Unicep’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