FDA applicant
Pacific Union Dental, Inc.
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
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.
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.
See the 510(k) Report