510(k) Report

FDA applicant

Danville Materials, Inc.

San Ramon, CA16 decisions2001–20150 recalls

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, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Danville Materials, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

5in 2015

2009: 32011: 32012: 12015: 5
2007high 5 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Danville Materials, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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Other applicant names beginning “Danville”

FDA records each applicant name separately; these may or may not be the same firm.