510(k) Report

Devices descending from K003226

400 later devices reach The Lifecore Stage-1 Single Stage RBM Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+5K220823Preat AbutmentsPreat Corporation202216
+5K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+5K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+5K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+5K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+5K201981Magicore SystemInnobiosurg Co., Ltd.20204—
+5K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+5K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+5K190637Fit & Brilliant Dental Implant SystemF&B Technology Co., Ltd.20200—
+5K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+5K192197Magicore II SystemInnobiosurg Co., Ltd.20203—
+5K193335SherlockOpen Implants, LLC20203—
+5K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+5K192263UCLA CCM AbutmentDio Corporation20204—
+5K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+5K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+5K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+5K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+5K163557SS SA FixtureOsstem Implant Co., Ltd.20173—
+5K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.20168—
+5K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+5K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+5K142313OneQ-SL Implant SystemDentis Co., Ltd.201519—
+5K140934Hiossen Implant SystemHiossen, Inc.201413—
+5K130662ET Prosthetic SystemOsstem Implant Co., Ltd.2014424
+5K123627ET Smartfit AbutmentHiossen, Inc.201321—
+5K123755Multi Angled AbutmentOsstem Implant Co., Ltd.201347—
+5K121585TS Implant SystemOsstem Implant Co., Ltd.201364—
+5K121995TS Fixture SystemOsstem Implant Co., Ltd.201224—
+5K121047Hero II Dental Implant System, IS Dental Implant SystemKj Meditech Co., Ltd.201214—
+5K120951Smartbuilder SystemOsstem Implant Co., Ltd.201214—
+5K113554Cmi Implant IS SystemNeobiotech Co., Ltd.201234—
+5K111120CSM Submerged-R Implant SystemCsm Implant20118—
+5K100850Cowell Implant SystemCowellmedi Co., Ltd.20104—
+5K091208GS Iii SystemOsstem Implant Co., Ltd.201028—
+5K090237HG II Fixture SystemHiossen, Inc.200938—
+5K082213GS Iii Fixture SystemOsstem Implant Co., Ltd.2008110—
+6K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+6K243278Custom AbutmentsInstitut Straumann AG202501
+6K241003HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)Hiossen, Inc.20250—
+6K242753SD TL Implant SystemArum Dentistry Co., Ltd.20251—
+6K240977DenQ Sub SLA Implant SystemDenq20240—
+6K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+6K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+6K233389EK Digital AbutmentsHiossen, Inc.20240—
+6K232528Protective CapNeobiotech Co., Ltd.20240—
+6K232049IS-III active Short ImplantNeobiotech Co., Ltd.20240—
+6K232268STERI-OSS Implant SystemZeros Co., Ltd.20241—
+6K233167LW Implant System – AbutmentOssvis Co., Ltd.20240—
+6K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+6K232546Meta G UCLA AbutmentCowellmedi Co., Ltd.20230—
+6K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+6K222778Osstem Implant SystemOsstem Implant Co., Ltd.20232—
+6K231079LW Retraction CapOssvis Co., Ltd.20230—
+6K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+6K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+6K222738Point implant systemPointnix Co., Ltd.20230—
+6K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+6K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+6K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+6K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+6K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+6K212702IM/ST Fixture SystemGuilin Fiteeth Medical Instrument Co., Ltd.20221—
+6K212664SherlockOpen Implants, LLC20212—
+6K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+6K212108Dynamic TiBaseTalladium España, SL20219—
+6K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+6K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+6K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+6K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+6K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+6K201621Magicore II SystemInnobiosurg Co., Ltd.20202—
+6K192274BV Dental Implant SystemBio Concept Co., Ltd.20200—
+6K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+6K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+6K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+6K181138IS-III active SystemNeobiotech Co., Ltd.201823—
+6K173938IS-III HActive FixtureNeobiotech Co., Ltd.20180—
+6K172630Kisses Plus Implant SystemAchimhai Medical Corporation20180—
+6K172354OssBuilder SystemOsstem Implant Co., Ltd.20183—
+6K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+6K171297AR_N Type Implant SystemBiotem Co., Ltd.20181—
+6K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+6K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+6K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+6K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+6K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691