510(k) Report

FDA applicant

Unicep

Sandpoint, ID9 decisions1993–19930 recalls

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, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

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.

FIG. 1 — Unicep by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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