510(k) Report

Devices descending from K093027

97 later devices reach Straumann RC Temporary Abutments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172100URIS OMNI SystemTruabutment, Inc.20187—
+1K170080Neodent Implant System - CM Pro PEEK AbutmentJjgc Industria E Comercio DE Materiais Dentarios S.A.20170—
+1K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+1K123638Pekkton IvoryCendres & Metaux SA20130—
+1K121585TS Implant SystemOsstem Implant Co., Ltd.201364—
+2K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+2K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+2K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+2K231566ICX-Implant SystemMedentis Medical GmbH20240—
+2K232049IS-III active Short ImplantNeobiotech Co., Ltd.20240—
+2K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+2K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+2K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+2K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+2K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+2K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+2K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+2K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+2K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+2K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+2K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+2K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+2K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+2K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+2K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+2K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+2K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+2K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+2K140934Hiossen Implant SystemHiossen, Inc.201413—
+2K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+3K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+3K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+3K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+3K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+3K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+3K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+3K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K232383iPhysio® SystemEuroteknika20250—
+3K232528Protective CapNeobiotech Co., Ltd.20240—
+3K233167LW Implant System – AbutmentOssvis Co., Ltd.20240—
+3K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+3K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+3K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+3K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+3K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+3K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+3K231079LW Retraction CapOssvis Co., Ltd.20230—
+3K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+3K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+3K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+3K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+3K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+3K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+3K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+3K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+3K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+3K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+3K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+3K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+3K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+3K153521IH Implant SystemSewonmedix, Inc.201610—
+3K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+3K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+4K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+4K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+4K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+4K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+4K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+4K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+4K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+4K222707IH Implant SystemSewonmedix, Inc.20231—
+4K222636ET Abutment SystemHiossen, Inc.20230—
+4K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+4K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+4K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+4K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+4K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+4K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+4K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+5K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+5K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+5K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+5K240977DenQ Sub SLA Implant SystemDenq20240—
+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—
+5K222976MU SystemDentis Co., Ltd.20230—
+5K220517IBS SystemInnobiosurg Co., Ltd.20220—
+5K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+5K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+5K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—