Atlas FDA

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

Den-Mat Holdings, LLC — Predicate Candidate Screening

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

128 daysmedian FDA review time
198 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K242097DenMat Bulk Fill CompositeDen-Mat Holdings, LLC2024-10-15890
K162967nuance UNIVERSALDen-Mat Holdings, LLC2017-03-241510
K143679Nuance FLOWDen-Mat Holdings, LLC2015-05-011280
K140537TENURE4GDen-Mat Holdings, LLC2014-08-201690
K110079SPPHINE PLUS STM 3W DIODE LASERDen-Mat Holdings, LLC2011-02-10300
K103667SAPPHIRE ST PORTABLE DIODE LASERDen-Mat Holdings, LLC2010-12-29140
K081287SAPPHIRE PLASMA ARC DENTAL CURING LIGHTDen-Mat Holdings, LLC2008-11-211980
K073483SAPPHIRE O/E ORAL EXAMINATION SYSTEMDen-Mat Holdings, LLC2008-04-031140

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