510(k) Report

Devices descending from K240304

2 later devices reach Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250710Injectable Root Canal Bioceramic Sealer (nRoot SP)Enpuno Co., Ltd.20251—
+2K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.20260—