510(k) Report

Devices descending from K052281

7 later devices reach Embrace Wetbond Clear Sealant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113818Embrace Wetbond Pit and Fissure Sealant, Low FillPulpdent Corporation20120—
+1K112517Ultraseal XT HydroUltradent Products, Inc.20111—
+1K073395Gilb-2, Glass Ionomer Protective Coating3M Espe Dental Products20083—
+2K232498UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioUltradent Product, Inc.20230—
+2K091632SPK Sealant3M Company20092—
+3K100062Infiltration KitDmg USA, Inc.20101—
+4K251124G-Bond UniversalGC America, Inc.20250—