510(k) Report

Devices descending from K912734

350 later devices reach Interpore Hex Head Implant Restorative Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+7K192742Straumann Variobase CInstitut Straumann AG20211—
+7K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+7K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+7K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+7K200355Duranext AbutmentsElegant Dental Corp.20200—
+7K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+7K193335SherlockOpen Implants, LLC20203—
+7K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+7K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+7K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+7K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+7K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+7K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+7K181037DIO CAD/CAM AbutmentDio Corporation20187—
+7K171532TruBase STruabutment, Inc.20187—
+7K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+7K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+7K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+7K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+7K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+7K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+7K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+7K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+7K153521IH Implant SystemSewonmedix, Inc.201610—
+7K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+7K160784CAM Titanium BlanksAltatec GmbH20161—
+7K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+7K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+7K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+7K130222Straumann Dental Implant SystemStraumann USA, LLC2013118—
+7K123784Straumann Dental Implant SystemStraumann USA, LLC2013122—
+7K113606NNC Gold Abutment for BridgesStraumann USA20120—
+8K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+8K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+8K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+8K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+8K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+8K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+8K243009Mist ICImagine Milling Technologies, LLC20251—
+8K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+8K243824Preat AbutmentsPreat Corporation20250—
+8K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+8K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+8K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+8K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+8K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+8K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+8K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+8K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+8K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+8K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+8K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+8K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+8K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+8K222707IH Implant SystemSewonmedix, Inc.20231—
+8K223663SIMDA AbutmentSimda Co., Ltd.20232—
+8K222636ET Abutment SystemHiossen, Inc.20230—
+8K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+8K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+8K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+8K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+8K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+8K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+8K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+8K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+8K212664SherlockOpen Implants, LLC20212—
+8K212108Dynamic TiBaseTalladium España, SL20219—
+8K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+8K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+8K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+8K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+8K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+8K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+8K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+8K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+8K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+8K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+8K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+8K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+8K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+8K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+8K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+8K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+9K261122Mist ICImagine Milling Technologies, LLC20260—
+9K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+9K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+9K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+9K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+9K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+9K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+9K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+9K240977DenQ Sub SLA Implant SystemDenq20240—
+9K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+9K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+9K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+9K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+9K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+9K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—