Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Danville Materials, LLC — Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

127 daysmedian FDA review time
167 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K152349Star+ VPS Scannable Impression MaterialDanville Materials, LLC2015-11-23950
K151514PrestigeDanville Materials, LLC2015-09-211080
K151088DMRC Bulk FillDanville Materials, LLC2015-08-281270
K142886DMRC Self-Cure Bracket Adhesive One Step and PrimerDanville Materials, LLC2015-03-181670
K142881DMRC Dual Cure Orthodontic Band CementDanville Materials, LLC2015-02-131340

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda