510(k) Report

Devices descending from K932078

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190339Helioseal F PlusIvoclar Vivadent, AG20190—
+1K122521Prevent SealItena Clinical20131—
+2K141717Pacseal Pit & Fissure SealantPac-Dent International, Inc.20150—