FDA applicant
Espe-Premier Sales Co.
FDA records 10 decisions for Espe-Premier Sales Co. (Mchenry, IL) in 1981: 10 510(k) clearances. Most are in product codes KLE (Agent, Tooth Bonding, Resin) 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
How often FDA has decided Espe-Premier Sales Co.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Espe-Premier Sales Co. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Espe-Premier Sales Co.’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) ReportOther applicant names beginning “Espe-Premier”
FDA records each applicant name separately; these may or may not be the same firm.