510(k) Report

Devices descending from K013198

5 later devices reach Fuji Vii Capsule through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193484GC Fuji Triage EPGC America, Inc.20200—
+1K073395Gilb-2, Glass Ionomer Protective Coating3M Espe Dental Products20083—
+2K091632SPK Sealant3M Company20092—
+3K100062Infiltration KitDmg USA, Inc.20101—
+4K251124G-Bond UniversalGC America, Inc.20250—