510(k) Report

Devices descending from K070857

43 later devices reach Nobeldirect 3.0-Immediate Load, 3.0 X 13 MM and 3.0 X 15 MM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080594MS System (Narrow Ridge)Osstem Implant Co., Ltd.200842—
+2K221317S-MonoShinhung Mst Co., Ltd.20230—
+2K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+2K112540S-Mini Implant SystemNeobiotech Co., Ltd.20125—
+2K083067MS SystemOsstem Implant Co., Ltd.20097—
+3K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+3K241127INNO SLA Mini Plus® Implant SystemCowellmedi Co., Ltd.20240—
+3K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+3K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+3K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+3K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+3K222636ET Abutment SystemHiossen, Inc.20230—
+3K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+3K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+3K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+3K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+3K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+3K181178S-mini active FixtureNeobiotech Co., Ltd.20180—
+3K170394Kisses MiniAchimhai Medical Corporation20170—
+3K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+3K133050One Plus Implant SystemOsseofuse, Inc.20141—
+3K122171MS SA Implant SystemOsstem Implant Co., Ltd.20122—
+4K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+4K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+4K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+4K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+4K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+4K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+4K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+4K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+4K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+4K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+4K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+4K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+4K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K222976MU SystemDentis Co., Ltd.20230—
+4K191201EM SA Implant SystemHiossen, Inc.20191—
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K242379LL Implant SystemOssvis Co., Ltd.20240—