510(k) Report

Devices descending from K941015

2 later devices reach Ormco System 1+ (TM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco Corporation20250—
+1K142886DMRC Self-Cure Bracket Adhesive One Step and PrimerDanville Materials, LLC20150—