510(k) Report

Devices descending from K190112

3 later devices reach Non-Sterile Zirconia Block through their predicates, nearest generation first.

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