510(k) Report

FDA applicant

Den-Tal-Ez Mfg Co., Inc.

Lancaster, PA7 decisions1978–19930 recalls

FDA records 7 decisions for Den-Tal-Ez Mfg Co., Inc. (Lancaster, PA) from 1978 to 1993: 7 510(k) clearances. Most are in product codes KLC (Chair, Dental, With Operative Unit) and EIA (Unit, Operative Dental). 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 Den-Tal-Ez Mfg Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Den-Tal-Ez Mfg Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Den-Tal-Ez Mfg 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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