FDA applicant
United Dental Mfg., Inc.
FDA records 5 decisions for United Dental Mfg., Inc. (Mchenry, IL) from 1981 to 1985: 5 510(k) clearances. Most are in product codes EKS (File, Pulp Canal, Endodontic) and EKN (Point, Paper, Endodontic). 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 United Dental Mfg., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for United Dental Mfg., Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like United Dental Mfg., 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