510(k) Report

Devices descending from K151626

9 later devices reach ET III Bio-SA Fixture System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+1K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+2K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+2K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+2K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+2K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+2K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+3K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+3K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—