510(k) Report

Devices descending from K880393

8 later devices reach Transbond Light Cured Orthodontic Adhesive through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco Corporation20250—
+1K210115FiteBac CC OrthoSealLargent Health, LLC20210—
+1K192682Orthocem, Ortho BiteDentscare Ltda20201—
+1K173020OBA-MCP, Orthodontic Bracket Adhesive with MCPPulpdent Corporation20180—
+1K160782BracePaste AdhesiveAmerican Orthodontics20161—
+1K161684Quantum LBReliance Orthodontic Products, Inc.20160—
+2K214054TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP…Tp Orthodontics, Inc.20220—
+2K210349TKO Composite Bite Turbo GelReliance Orthodontic Products, Inc.20210—