FDA applicant
American Dental Products, Inc.
FDA records 23 decisions for American Dental Products, Inc. (Medinah, IL) from 1995 to 2010: 23 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and DYH (Adhesive, Bracket And Tooth Conditioner, Resin). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 American Dental Products, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2010
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like American Dental Products, 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