510(k) Report

Devices descending from K173275

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

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