510(k) Report

Devices descending from K073070

16 later devices reach Dio Biotite-H Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133362SGS Dental ImplantSgs International, Ltd.20142—
+1K112532ET II Bio-SA Fixture SystemHiossen, Inc.201210—
+1K111364Haptite Coating Implant SystemDentis Co., Ltd.20121—
+2K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+2K173938IS-III HActive FixtureNeobiotech Co., Ltd.20180—
+2K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+3K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+3K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+3K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+4K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+4K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+4K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+4K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+4K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+5K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+5K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—