510(k) Report

FDA applicant

Pacific Union Dental, Inc.

Silver Spring, MD5 decisions1986–19860 recalls

FDA records 5 decisions for Pacific Union Dental, Inc. (Silver Spring, MD) in 1986: 5 510(k) clearances. Most are in product codes ELW (Material, Impression) and JES (Floss, 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 Pacific Union Dental, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pacific Union Dental, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Pacific Union Dental, 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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