510(k) Report

Devices descending from K181037

7 later devices reach DIO CAD/CAM Abutment through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+1K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+1K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+1K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+1K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+2K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+2K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—