510(k) Report

Devices descending from K981516

1,066 later devices reach Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K222368Mist ICImagine Milling Technologies, LLC20222—
+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—
+6K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+6K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+6K220823Preat AbutmentsPreat Corporation202216
+6K212702IM/ST Fixture SystemGuilin Fiteeth Medical Instrument Co., Ltd.20221—
+6K211872PiezoImplant SystemRex Implants, Inc.20220—
+6K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+6K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+6K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+6K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+6K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+6K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+6K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+6K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+6K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+6K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+6K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+6K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+6K211225MIS Ti-base abutmentDentsply Sirona20210—
+6K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+6K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+6K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+6K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+6K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+6K202909CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20210—
+6K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+6K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+6K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+6K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+6K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+6K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+6K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+6K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+6K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+6K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+6K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+6K192221Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2…Implant Direct Sybron Manufacturing, LLC202032
+6K192274BV Dental Implant SystemBio Concept Co., Ltd.20200—
+6K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+6K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+6K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+6K193335SherlockOpen Implants, LLC20203—
+6K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+6K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+6K190406SDS2.2 dental implantSds Swiss Dental Solutions AG20200—
+6K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+6K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+6K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+6K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+6K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+6K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20191—
+6K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+6K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+6K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+6K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+6K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+6K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+6K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+6K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+6K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+6K170732Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20180—
+6K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+6K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+6K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+6K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+6K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+6K172630Kisses Plus Implant SystemAchimhai Medical Corporation20180—
+6K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+6K171179BR Type Implant SystemBiotem Co., Ltd.20181—
+6K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+6K171185IR Type Implant SystemBiotem Co., Ltd.20171—
+6K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+6K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+6K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+6K170031Internal Octa Implant SystemEbi, Inc.20171—
+6K161177Axiom PXAnthogyr Sas20170—
+6K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+6K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+6K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+6K163557SS SA FixtureOsstem Implant Co., Ltd.20173—
+6K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+6K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+6K162390ET Hybrid AbutmentHiossen, Inc.20172—
+6K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+6K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.20168—
+6K160786RODO Abutment SystemRodo Medical, Inc.20162—
+6K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+6K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+6K153521IH Implant SystemSewonmedix, Inc.201610—
+6K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+6K160784CAM Titanium BlanksAltatec GmbH20161—
+6K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+6K160213s-Clean Tapered II RBM Implant SystemDentis Co., Ltd.20160—
+6K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+6K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+6K142313OneQ-SL Implant SystemDentis Co., Ltd.201519—
+6K1505713i T3 Short ImplantsBiomet 3i20151—
+6K151324Straumann Variobase for CERECStraumann USA, LLC201513—