510(k) Report

Devices descending from K193425

4 later devices reach Pre-Milled Blank through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+2K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+2K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+3K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—