FDA applicant
Danville Materials, Inc.
FDA records 16 decisions for Danville Materials, Inc. (San Ramon, CA) from 2001 to 2015: 16 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and KLE (Agent, Tooth Bonding, Resin). Its devices cite 18 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Danville Materials, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Danville Materials, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2015
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Danville Materials, 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) ReportOther applicant names beginning “Danville”
FDA records each applicant name separately; these may or may not be the same firm.