510(k) Report

Devices descending from K160367

6 later devices reach Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191631ZMAXX Dental Zirconia BlanksZmaxx Bioceramics, LLC20190—
+1K180252Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded BlankCrown Porcelain Dental Technology Co., Ltd.20184—
+2K190112Non-Sterile Zirconia BlockFine Advanced Compound Co., Ltd.20193—
+3K223253Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)Arum Dentistry Co., Ltd.20231—
+3K201492Non-Sterile Zirconia BlockBioden Co., Ltd.20210—
+4K250063ARENA Star, Galaxy StarArum Dentistry Co., Ltd.20250—