510(k) Report

Devices descending from K070478

283 later devices reach P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+5K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+5K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+5K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+5K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+5K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+5K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+5K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+5K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+5K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+5K142167Medentika Abutment SystemMedentika GmbH20157—
+5K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+5K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+6K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+6K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+6K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+6K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+6K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+6K240977DenQ Sub SLA Implant SystemDenq20240—
+6K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+6K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+6K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+6K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+6K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+6K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+6K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+6K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+6K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+6K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+6K222976MU SystemDentis Co., Ltd.20230—
+6K220517IBS SystemInnobiosurg Co., Ltd.20220—
+6K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+6K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+6K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+6K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+6K212538DESS Dental ImplantsTerrats Medical SL20211—
+6K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+6K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+6K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+6K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+6K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+6K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+6K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+6K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+6K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+6K182246Mist ICImagine Milling Technologies, LLC20194—
+6K183518Preat AbutmentsPreat Corporation2019223
+6K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+6K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+6K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+6K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+6K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+6K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+6K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+6K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+6K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+6K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+7K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+7K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+7K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+7K253341Custom Abutments ASMedentika GmbH20250—
+7K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+7K251280DESS® Dental ImplantsTerrats Medical SL20250—
+7K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+7K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+7K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+7K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+7K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+7K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+7K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+7K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+7K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+7K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+7K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+7K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+7K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+7K222368Mist ICImagine Milling Technologies, LLC20222—
+7K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+7K220823Preat AbutmentsPreat Corporation202216
+7K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+7K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+7K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+7K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+7K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+7K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+7K200355Duranext AbutmentsElegant Dental Corp.20200—
+7K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+7K193335SherlockOpen Implants, LLC20203—
+7K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+7K181037DIO CAD/CAM AbutmentDio Corporation20187—
+7K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+7K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+7K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—