510(k) Report

Devices descending from K042658

441 later devices reach Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+5K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+5K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+5K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+5K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+5K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+5K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+5K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+5K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+5K221107TRUSTRgorithm Korea20230—
+5K221488Z7 Zirconia Implant SystemZ7, LLC20230—
+5K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+5K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+5K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+5K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+5K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+5K220823Preat AbutmentsPreat Corporation202216
+5K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+5K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+5K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+5K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+5K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+5K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+5K211225MIS Ti-base abutmentDentsply Sirona20210—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K202909CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20210—
+5K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+5K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+5K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+5K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K193335SherlockOpen Implants, LLC20203—
+5K190406SDS2.2 dental implantSds Swiss Dental Solutions AG20200—
+5K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+5K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+5K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+5K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+5K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+5K182246Mist ICImagine Milling Technologies, LLC20194—
+5K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+5K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+5K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+5K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+5K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+5K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+5K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+5K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+5K162390ET Hybrid AbutmentHiossen, Inc.20172—
+5K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+5K160784CAM Titanium BlanksAltatec GmbH20161—
+5K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+5K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+5K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+5K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+5K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+5K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+5K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+5K120414Osseospeed PlusAstra Tech AB2012196—
+6K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+6K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+6K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+6K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+6K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+6K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+6K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+6K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+6K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+6K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+6K233389EK Digital AbutmentsHiossen, Inc.20240—
+6K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+6K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+6K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+6K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+6K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+6K223663SIMDA AbutmentSimda Co., Ltd.20232—
+6K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+6K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+6K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+6K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+6K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+6K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+6K222368Mist ICImagine Milling Technologies, LLC20222—
+6K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+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—
+6K213599SuperLineDentium Co., Ltd.20220—
+6K212664SherlockOpen Implants, LLC20212—
+6K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+6K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+6K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+6K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+6K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—