Atlas FDA

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

3M Espe Dental Products — Predicate Candidate Screening

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

30 daysmedian FDA review time
79 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K2313383M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment3M Espe Dental Products2023-05-1020
K2302703M™ VitCal Liner/Base3M Espe Dental Products2023-02-0660
K1911223M RelyX Pediatric Resin Modified Glass Ionomer Cement3M Espe Dental Products2019-05-29300
K1834763M Filtek Universal Restorative3M Espe Dental Products2019-01-02160
K141081FILTEK BULK FILL POSTERIOR RESTROATIVE3M Espe Dental Products2014-05-08130
K120453FILTEK BULK FILL FLOWABLE RESTORATIVE3M Espe Dental Products2012-03-19340
K111185RELYX LUTING PLUS AUTOMIX3M Espe Dental Products2011-05-0580
K110131LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTI3M Espe Dental Products2011-01-2131
K092141VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH3M Espe Dental Products2010-03-102380
K073395GILB-2, GLASS IONOMER PROTECTIVE COATING3M Espe Dental Products2008-01-17450
K070956SEA2 SELF ETCH ADHESIVE3M Espe Dental Products2007-05-22470
K062292UNICEM3M Espe Dental Products2006-10-25790

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