510(k) Report

Devices descending from K010267

4 later devices reach Palfique Estelite LV Clear through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173275OmnichromaTokuyama Dental Corporation20183—
+2K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW…DiaDent Group International20260—
+2K193537Omnichroma FlowTokuyama Dental Corporation20201—
+3K203598Omnichroma Flow BulkTokuyama Dental Corporation20210—