510(k) Report

Devices descending from K941899

103 later devices reach Sdi Composties through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K223253Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)Arum Dentistry Co., Ltd.20231—
+10K201492Non-Sterile Zirconia BlockBioden Co., Ltd.20210—
+11K250063ARENA Star, Galaxy StarArum Dentistry Co., Ltd.20250—