Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Danville Materials, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
82 daysmedian FDA review time
98 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121880 | DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ET | Danville Materials, Inc. | 2012-09-25 | 89 | 0 |
| K111876 | Z BOND, PRELUDE ONE | Danville Materials, Inc. | 2011-09-21 | 82 | 0 |
| K110642 | SILJETR SYSTEM | Danville Materials, Inc. | 2011-05-27 | 81 | 0 |
| K102753 | TURBO TEMP 3 | Danville Materials, Inc. | 2011-02-04 | 134 | 0 |
| K092912 | STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND S | Danville Materials, Inc. | 2009-12-16 | 85 | 0 |
| K092319 | STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST H | Danville Materials, Inc. | 2009-09-16 | 43 | 0 |
| K090106 | PRELUDE ONE | Danville Materials, Inc. | 2009-03-31 | 89 | 0 |
| K040952 | PRELUDE | Danville Materials, Inc. | 2004-06-29 | 78 | 0 |
| K033215 | PREPAIR | Danville Materials, Inc. | 2004-01-09 | 98 | 0 |
| K020760 | STARFLOW HV | Danville Materials, Inc. | 2002-05-03 | 57 | 0 |
| K012354 | SNOWPOST, SNOWLIGHT | Danville Materials, Inc. | 2001-10-10 | 77 | 0 |
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