510(k) Report

Devices descending from K971578

1,113 later devices reach Endosseous Dental Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+5K221910QRS Dental Implants SystemQrs Medical, Ltd.20220—
+5K222368Mist ICImagine Milling Technologies, LLC20222—
+5K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+5K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+5K220823Preat AbutmentsPreat Corporation202216
+5K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+5K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+5K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+5K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+5K220022TRATE Dental Implant SystemTrate AG20221—
+5K213672T3 Pro ImplantsBiomet 3i, LLC20222—
+5K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+5K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+5K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+5K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K211992Ortho MI SystemOsteonic Co., Ltd.20210—
+5K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K203554AnyOne External Implant SystemMegagen Implant Co., Ltd.20210—
+5K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+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—
+5K210886MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona20210—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+5K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+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—
+5K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+5K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+5K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+5K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+5K200386Z5-BLZ-Systems AG20200—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+5K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+5K200102MIS Dental Implant SystemDentsply Sirona20200—
+5K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+5K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+5K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+5K200355Duranext AbutmentsElegant Dental Corp.20200—
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+5K193335SherlockOpen Implants, LLC20203—
+5K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+5K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+5K190919ST Internal Implant SystemT-Plus Implant Tech. Co., Ltd.20200—
+5K191054Southern Implants MAX Implant SystemSouthern Implants (Pty), Ltd.20191—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+5K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+5K191201EM SA Implant SystemHiossen, Inc.20191—
+5K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+5K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+5K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+5K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+5K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+5K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+5K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+5K181037DIO CAD/CAM AbutmentDio Corporation20187—
+5K173701Implant-One SystemImplant Logistics, Inc.20181—
+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—
+5K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20186—
+5K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+5K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+5K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+5K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+5K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+5K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+5K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+5K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+5K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+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—
+5K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+5K162390ET Hybrid AbutmentHiossen, Inc.20172—
+5K160991Neo GBR SystemNeobiotech Co., Ltd.20171—
+5K161197Orthodontic ScrewOsstem Implant Co., Ltd.20162—
+5K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+5K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.20168—
+5K163043Zeramex P6 Dental Implant SystemDentalpoint AG20160—
+5K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+5K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+5K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+5K160784CAM Titanium BlanksAltatec GmbH20161—
+5K142846BBX1, BBX2, BBX1MO, BBX1MCGlobaldental, Inc.20160—
+5K160119NobelSpeedy GroovyNobel Biocare AB20167—
+5K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+5K152845Allied Biocompat Abutment for Nobel Replace InterfaceAllied Dental Solutions20160—
+5K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+5K142313OneQ-SL Implant SystemDentis Co., Ltd.201519—
+5K143515Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and…Prismatik Dentalcraft, Inc.20150—
+5K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+5K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+5K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—