510(k) Report

Devices descending from K954512

702 later devices reach Restore Self Tapping Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K203554AnyOne External Implant SystemMegagen Implant Co., Ltd.20210—
+5K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+5K193352AbutmentCADExocad GmbH20210—
+5K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+5K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+5K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+5K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+5K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+5K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+5K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+5K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+5K202452NobelProcera Zirconia Implant BridgeNobel Biocare AB20202—
+5K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+5K200100Abutment Design3Shape A/S20203—
+5K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+5K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+5K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+5K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+5K191152MIS Ti-base AbutmentDentsply Sirona20201—
+5K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+5K193335SherlockOpen Implants, LLC20203—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+5K190552JJ Implant SystemJj Implants20190—
+5K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+5K181953SDS1.2 dental implantSds Swiss Dental Solutions AG20191—
+5K191201EM SA Implant SystemHiossen, Inc.20191—
+5K192053W Zirconia ImplantsTav Medical, Ltd.20191—
+5K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+5K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+5K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+5K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+5K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+5K181932DTX Studio designNobel Biocare AB20190—
+5K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+5K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+5K181037DIO CAD/CAM AbutmentDio Corporation20187—
+5K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+5K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+5K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+5K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+5K172240SPI Dental Implant SystemMsi France20180—
+5K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+5K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+5K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+5K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+5K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+5K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+5K170100CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20170—
+5K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+5K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+5K163557SS SA FixtureOsstem Implant Co., Ltd.20173—
+5K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20171—
+5K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+5K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+5K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+5K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+5K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.20168—
+5K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+5K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+5K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+5K160436CreoDent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20160—
+5K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+5K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+5K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+5K142313OneQ-SL Implant SystemDentis Co., Ltd.201519—
+5K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+5K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+5K151599iSy Implant SystemAltatec GmbH20150—
+5K143515Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and…Prismatik Dentalcraft, Inc.20150—
+5K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+5K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+5K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+5K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+5K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+5K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+5K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+5K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+5K141950HFD100 Rocker Arm AccessoryImris, Inc.20140—
+5K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+5K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+5K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+5K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+5K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+5K130662ET Prosthetic SystemOsstem Implant Co., Ltd.2014424
+5K131701Z5MLB, Z5MLCZ-Systems AG20131—
+5K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+5K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+5K123988Anyonetm Internal Implant SystemMegagen Implant Co., Ltd.201319—
+5K123471Etii SA Fixture SystemHiossen, Inc.201314—
+5K121281Simpli Simpler Implant SystemSimpler Implant Solutions20130—
+5K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+5K123870Xpeed Anyridge Internal Implant SystemMegagen Implant Co., Ltd.20131—
+5K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+5K121585TS Implant SystemOsstem Implant Co., Ltd.201364—
+5K121117NDX AbutmentsNational Dentex Corp20120—