510(k) Report

Devices descending from K110178

3 later devices reach Estelite Color through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161353ESTELITE BULK FILL FlowTokuyama Dental Corporation20172—
+2K203598Omnichroma Flow BulkTokuyama Dental Corporation20210—
+2K180613Estelite Universal FlowTokuyama Dental Corporation20180—