Atlas FDA

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

Denali Corporation — Predicate Candidate Screening

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

115 daysmedian FDA review time
225 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K153191Calcium BridgeDenali Corporation2016-02-261150
K151945Triumph Resin DamDenali Corporation2016-02-182190
K152322Resolve 2.0Denali Corporation2015-12-161210
K141503DENALI 501CEMENTDenali Corporation2014-11-101570
K132393CERCOM II CEMENTDenali Corporation2014-03-142250
K073101AURAVENEER CEMENTDenali Corporation2008-01-17930
K071158AURALAY PIT & FISSURE SEALANTDenali Corporation2007-06-05410
K070702FUSION RESIN CEMENT AND CORE KITDenali Corporation2007-05-10580
K070693AURAVUE PIT & FISSURE SEALANTDenali Corporation2007-05-09570

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