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
+7K222707IH Implant SystemSewonmedix, Inc.20231—
+7K222142BR SLA Type Implant SystemBiotem Co., Ltd.20230—
+7K223535SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC202301
+7K222144IR SLA Type Implant SystemBiotem Co., Ltd.20230—
+7K223663SIMDA AbutmentSimda Co., Ltd.20232—
+7K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+7K222636ET Abutment SystemHiossen, Inc.20230—
+7K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+7K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+7K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+7K221966Dynamic TiBaseTalladium Espana, SL20225—
+7K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+7K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+7K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio…Blue Sky Bio, LLC20223—
+7K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+7K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+7K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+7K210039CORE1 Implant SystemCybermed, Inc.20220—
+7K212664SherlockOpen Implants, LLC20212—
+7K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+7K212108Dynamic TiBaseTalladium España, SL20219—
+7K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+7K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+7K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+7K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+7K192742Straumann Variobase CInstitut Straumann AG20211—
+7K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+7K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+7K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+7K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+7K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+7K190837Internal Hex Implant SystemEbi, Inc.20200—
+7K191123Multi-unit AbutmentsMedentika GmbH202011—
+7K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+7K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+7K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+7K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+7K181137IT-III active SystemNeobiotech Co., Ltd.20183—
+7K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+7K171532TruBase STruabutment, Inc.20187—
+7K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+7K180609Rodo SmilekeyRodo Medical, Inc.20180—
+7K170421ET Hybrid AbutmentHiossen, Inc.20180—
+7K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+7K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+7K170394Kisses MiniAchimhai Medical Corporation20170—
+7K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+7K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+7K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+7K151757IMMEDIATELOAD Dental Implant SystemImmediateload S.A.20160—
+7K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+7K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+7K151588maxFit II Dental Implant SystemTaiwan Implant Technology Company, Ltd.20160—
+7K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+7K151194Klockner Dental Implant Abutments (II)Soadco, S.L.20164—
+7K152520Magicore SystemInnobiosurg Co., Ltd.20167—
+7K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+7K140347Ankylos C/X Implant SystemDentsply Intl., Inc.20146—
+7K130694JR Implant SystemLK Consulting Group USA, Inc.20140—
+7K131345Tiarray Dental Implant SystemNasseo, Inc.20130—
+7K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG201311—
+7K122804Royal-Dent Eureka Dental Implant SystemIntai Technology Corp.20130—
+7K121843NP-Cast Abutment SystemOsstem Implant Co., Ltd.201254—
+7K110308Prosthetic SystemOsstem Implant Co., Ltd.2011105—
+7K102804Spi Titanium Base for Cad/CamThommen Medical AG201183—
+7K101890Ball Abutment SystemMegagen Co., Ltd.20110—
+7K100245HS/HG Prosthetic SystemOsstem Implant Co., Ltd.2010111—
+7K100511Cotec Dental Implant SystemCotec Implant Co., Ltd.20100—
+7K093889Modification to: HG Iii Ultra Wide SystemHiossen, Inc.201038—
+7K090825SQ IS SystemNeobiotech Co., Ltd.200955—
+7K082843Modificaton to: Dentis Dental Implant SystemDentis Co., Ltd.20091—
+7K081851Neoss Access AbutmentsNeoss, Ltd.20090—
+7K081786Ziocera & Convertible SystemOsstem Implant Co., Ltd.2008123—
+7K080744HG II Fixture SystemOsstem Implant Co., Ltd.2008112—
+7K073142Nobelreplace Hexagonal ImplantNobel Biocare USA, LLC2008952
+7K072570Nobelactive Multi Unit AbutmentNobel Biocare AB20071811
+7K072980Nobelperfect Conical Connection Hexagonal ImplantsNobel Biocare AB20070—
+7K072896GS Fixture SystemOsstem Implant Co., Ltd.200715—
+7K071370Nobelactive Internal Connection ImplantNobel Biocare AB20074144
+7K063718SFB and CFB Implants - 5.0 PlatformNobel Biocare AB20070—
+7K062749SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP, Model…Nobel Biocare AB2006327—
+8K260940BellaTek BarsZimVie US Corp, LLC20260—
+8K261122Mist ICImagine Milling Technologies, LLC20260—
+8K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+8K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG20260—
+8K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+8K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+8K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+8K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+8K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+8K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+8K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+8K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+8K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+8K240977DenQ Sub SLA Implant SystemDenq20240—
+8K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+8K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+8K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+8K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—