510(k) Report

Devices descending from K180252

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190112Non-Sterile Zirconia BlockFine Advanced Compound Co., Ltd.20193—
+2K223253Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)Arum Dentistry Co., Ltd.20231—
+2K201492Non-Sterile Zirconia BlockBioden Co., Ltd.20210—
+3K250063ARENA Star, Galaxy StarArum Dentistry Co., Ltd.20250—