510(k) Report

Devices descending from K002188

395 later devices reach Swissplus Implant System, Model SPWB 8,10,12,14/OPH20/SMPR, SPB… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+6K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+6K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+6K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+6K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+6K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K241003HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)Hiossen, Inc.20250—
+6K242753SD TL Implant SystemArum Dentistry Co., Ltd.20251—
+6K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240977DenQ Sub SLA Implant SystemDenq20240—
+6K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+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—
+6K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+6K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+6K232546Meta G UCLA AbutmentCowellmedi Co., Ltd.20230—
+6K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+6K222778Osstem Implant SystemOsstem Implant Co., Ltd.20232—
+6K231079LW Retraction CapOssvis Co., Ltd.20230—
+6K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+6K222738Point implant systemPointnix Co., Ltd.20230—
+6K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+6K212702IM/ST Fixture SystemGuilin Fiteeth Medical Instrument Co., Ltd.20221—
+6K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+6K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+6K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+6K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+6K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+6K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+6K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+6K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+6K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+6K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+6K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+6K201621Magicore II SystemInnobiosurg Co., Ltd.20202—
+6K192274BV Dental Implant SystemBio Concept Co., Ltd.20200—
+6K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+6K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+6K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+6K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+6K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+6K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+6K182246Mist ICImagine Milling Technologies, LLC20194—
+6K183518Preat AbutmentsPreat Corporation2019223
+6K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+6K181138IS-III active SystemNeobiotech Co., Ltd.201823—
+6K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+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
+6K152559TruAbutment DSTruabutment201618—
+6K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+6K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+6K142813Biogensis Implant System-KissesBiogenesis Co., Ltd.20151—
+6K150060J2A Dental Implant System, J2C Dental Implant SystemKj Meditech Co., Ltd.20152—
+6K140600SB AnchorOsstem Implant Co., Ltd.20144—
+6K132144KeratorLK Consulting Group USA, Inc.20140—
+6K132067Multi Angled Abutment SystemHiossen, Inc.201333—
+6K132242Inno Sla Submerged Implant SystemCowellmedi Co., Ltd.20133—
+6K131682UD Implant SystemMedimecca Co., Ltd.20135—
+6K131165Anker Dental Implant SystemAlliance Global20131—
+6K130840Smartbuilder System (SB1)Osstem Implant Co., Ltd.20130—
+6K123471Etii SA Fixture SystemHiossen, Inc.201314—
+6K130221Hero II Dental Implant System, UI Dental Implant SystemMedimecca Co., Ltd.20130—
+6K120089Biogenesis Implant SystemBiogenesis Co., Ltd.20130—
+6K121098Hero I Dental Implant SystemKj Meditech Co., Ltd.20130—
+6K120503Cmi Implant IS II ActiveNeobiotech Co., Ltd.20129—
+6K093352HG Iii Fixture SystemHiossen, Inc.2009105—
+7K260463ZEROS Dental Implant SystemZeros Co., Ltd.20260—
+7K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+7K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+7K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+7K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+7K250280SD TL Implant SystemArum Dentistry Co., Ltd.20250—
+7K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+7K243278Custom AbutmentsInstitut Straumann AG202501
+7K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+7K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+7K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+7K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+7K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+7K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+7K223924LW Implant SystemOssvis Co., Ltd.20231—
+7K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+7K221301DESS Dental Smart SolutionsTerrats Medical SL20233—