510(k) Report

Devices descending from K011200

6 later devices reach Gilb, Model 8010 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2302703M™ VitCal Liner/Base3M Espe Dental Products20231—
+1K073395Gilb-2, Glass Ionomer Protective Coating3M Espe Dental Products20083—
+2K261728One-Fil LCMediclus Co., Ltd.20260—
+2K091632SPK Sealant3M Company20092—
+3K100062Infiltration KitDmg USA, Inc.20101—
+4K251124G-Bond UniversalGC America, Inc.20250—