510(k) Report

Devices descending from K103528

2 later devices reach Ips Empress Direct Flow through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122521Prevent SealItena Clinical20131—
+2K141717Pacseal Pit & Fissure SealantPac-Dent International, Inc.20150—