510(k) Report

FDA applicant

Jedental Co., Inc.

Southampton, PA8 decisions1993–19940 recalls

FDA records 8 decisions for Jedental Co., Inc. (Southampton, PA) from 1993 to 1994: 8 510(k) clearances. Most are in product codes EMA (Cement, Dental) and EBF (Material, Tooth Shade, Resin). 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 Jedental Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Jedental Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Jedental Co., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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