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
+8K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+8K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+8K231559Multi-Unit DAS SystemTalladium España, SL20231—
+8K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+8K232271SIMDA abutmentSimda Co., Ltd.20230—
+8K232151Dynamic TiBaseTalladium España, SL20232—
+8K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+8K221673Bonafix TiBaseZentek Medical, LLC20231—
+8K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+8K222792SNUCONE Tissue Level Implant SystemSnucone Co., Ltd.20232—
+8K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+8K230103Klockner AbutmentsSoadco, S.L.20230—
+8K212394Implant-One Multi-Unit AbutmentImplant Logistics, Inc.20230—
+8K222976MU SystemDentis Co., Ltd.20230—
+8K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+8K220517IBS SystemInnobiosurg Co., Ltd.20220—
+8K220339Esthetic Abutments Nobel Biocare N1Nobel Biocare Services AG20220—
+8K220482SherlockOpen Implants, LLC20221—
+8K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+8K213391High Retention Attachment SystemZest Anchors, LLC20227—
+8K200193Kisses Plus Implant SystemAchimhai Medical Corporation20210—
+8K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+8K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+8K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+8K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+8K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+8K201981Magicore SystemInnobiosurg Co., Ltd.20204—
+8K192197Magicore II SystemInnobiosurg Co., Ltd.20203—
+8K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+8K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+8K192263UCLA CCM AbutmentDio Corporation20204—
+8K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+8K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+8K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+8K183079Conometric AbutmentsDentsply Sirona, Inc.20190—
+8K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+8K172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical…Mis Implants Technologies, Ltd.20174—
+8K170372SpiralTech Dental Implant SystemSpiraltech Superior Dental Implants, Inc.20178—
+8K161416Multi-unit Abutment PlusNobel Biocare AB201774—
+8K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+8K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+8K1516084plus6Line Abutment SystemOt Medical GmbH20160—
+8K143142JDENTALCARE Implant SystemJdentalcare Srl20152—
+8K150968TRU Dental Implant SystemSterngold Dental, LLC20150—
+8K123627ET Smartfit AbutmentHiossen, Inc.201321—
+8K123755Multi Angled AbutmentOsstem Implant Co., Ltd.201347—
+8K121047Hero II Dental Implant System, IS Dental Implant SystemKj Meditech Co., Ltd.201214—
+8K120951Smartbuilder SystemOsstem Implant Co., Ltd.201214—
+8K113554Cmi Implant IS SystemNeobiotech Co., Ltd.201234—
+8K111935TI-Base Abutment, 1 Connect AbutmentNt-Trading GmbH and CO KG201264—
+8K111120CSM Submerged-R Implant SystemCsm Implant20118—
+8K102034Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC20114—
+8K101732Astra Tech Implant SystemAstra Tech AB2011214—
+8K100850Cowell Implant SystemCowellmedi Co., Ltd.20104—
+8K102436Nobel Active 3.0Nobel Biocare AB2010203—
+8K101755Aidi Dental Implant SystemAidi Biomedical, LLC20101—
+8K090081Talladium International Implantology AbutmentsTalladium Espana, SL20100—
+8K091208GS Iii SystemOsstem Implant Co., Ltd.201028—
+8K093483Atlantis Abutment for Nobel Biocare Active Implant, Atlantis Gemini Abutment, Gemini +…Astra Tech, Inc.200967—
+8K090237HG II Fixture SystemHiossen, Inc.200938—
+8K083205Nobelactive 8.5 MM & 18.0 MMNobel Biocare AB2009103—
+8K083100Goldadapt Non-Engaging Nobelactive NP & RP, Goldadapt Engaging Nobelactive NP & RPNobel Biocare USA, LLC20081—
+8K081806Idi Implant SystemIdi Biomedical, LLC20082—
+8K082213GS Iii Fixture SystemOsstem Implant Co., Ltd.2008110—
+8K072129Nobelactive Zirconia AbutmentNobel Biocare AB200871—
+8K070533Bti Endosseous Dental Implant Angled AbutmentsB.T.I. Biotechnology Institute, Sl.20070—
+9K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+9K243732Multi-Unit DAS SystemTalladium España, SL20260—
+9K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+9K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+9K250967SherlockOpen Implants, LLC20250—
+9K243530Dynamic TiBaseTalladium España, SL20250—
+9K242064Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20251—
+9K241003HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)Hiossen, Inc.20250—
+9K241692MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20242—
+9K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+9K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+9K232546Meta G UCLA AbutmentCowellmedi Co., Ltd.20230—
+9K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+9K221381KDG AbutmentsKeystone Dental, Inc.20220—
+9K220252High Retention Attachment SystemZest Anchors, LLC20221—
+9K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+9K201842TruBase STruabutment, Inc.20210—
+9K200329IDCAM Dental ImplantsImplants Diffusion International20210—
+9K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+9K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+9K201621Magicore II SystemInnobiosurg Co., Ltd.20202—
+9K182081JDentalCare Implant System JDIconJdentalcare Srl20201—
+9K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+9K200188DSI Dental Implant SystemDsi Dental Solutions, Ltd.20200—
+9K182293OsseOne Dental Implant SystemSynoross Dba Osseone20195—
+9K181138IS-III active SystemNeobiotech Co., Ltd.201823—
+9K173938IS-III HActive FixtureNeobiotech Co., Ltd.20180—
+9K172354OssBuilder SystemOsstem Implant Co., Ltd.20183—
+9K171297AR_N Type Implant SystemBiotem Co., Ltd.20181—
+9K163349MIS V3 Conical Connection Dental Implant System­Mis Implants Technologies, Ltd.20178—
+9K152559TruAbutment DSTruabutment201618—
+9K150060J2A Dental Implant System, J2C Dental Implant SystemKj Meditech Co., Ltd.20152—
+9K140600SB AnchorOsstem Implant Co., Ltd.20144—
+9K132067Multi Angled Abutment SystemHiossen, Inc.201333—