510(k) Report

Devices descending from K053354

45 later devices reach Intermezzo Plus Fixture through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080129Secure Implant System (2.5/3.0MM)Dio Department Dsi, Inc.20080—
+1K072959MS System (Denture)Osstem Implant Co., Ltd.200843—
+2K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+2K112540S-Mini Implant SystemNeobiotech Co., Ltd.20125—
+2K083067MS SystemOsstem Implant Co., Ltd.20097—
+2K080594MS System (Narrow Ridge)Osstem Implant Co., Ltd.200842—
+3K241127INNO SLA Mini Plus® Implant SystemCowellmedi Co., Ltd.20240—
+3K221317S-MonoShinhung Mst Co., Ltd.20230—
+3K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+3K181178S-mini active FixtureNeobiotech Co., Ltd.20180—
+3K170394Kisses MiniAchimhai Medical Corporation20170—
+3K133050One Plus Implant SystemOsseofuse, Inc.20141—
+3K122171MS SA Implant SystemOsstem Implant Co., Ltd.20122—
+4K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+4K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+4K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+4K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+4K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+4K222636ET Abutment SystemHiossen, Inc.20230—
+4K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+4K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+4K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+4K191201EM SA Implant SystemHiossen, Inc.20191—
+5K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+5K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+5K242379LL Implant SystemOssvis Co., Ltd.20240—
+5K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+5K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+5K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+5K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+5K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+5K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K222976MU SystemDentis Co., Ltd.20230—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—