FDA applicant
Den-Mat Corp.
FDA records 29 decisions for Den-Mat Corp. (Santa Maria, CA) from 1977 to 1999: 29 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EMA (Cement, 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 Den-Mat Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Den-Mat Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Den-Mat Corp.’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