510(k) Report

Devices descending from K062749

327 later devices reach SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K233389EK Digital AbutmentsHiossen, Inc.20240—
+5K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+5K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+5K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+5K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+5K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+5K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+5K221107TRUSTRgorithm Korea20230—
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+5K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+5K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+5K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+5K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+5K212664SherlockOpen Implants, LLC20212—
+5K212108Dynamic TiBaseTalladium España, SL20219—
+5K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+5K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+5K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+5K211225MIS Ti-base abutmentDentsply Sirona20210—
+5K202909CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20210—
+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—
+5K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+5K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+5K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+5K182246Mist ICImagine Milling Technologies, LLC20194—
+5K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+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—
+5K170421ET Hybrid AbutmentHiossen, Inc.20180—
+5K171795Thommen Implant SystemThommen Medical AG20170—
+5K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+5K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+5K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+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—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+6K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+6K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+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—
+6K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+6K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+6K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+6K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+6K223663SIMDA AbutmentSimda Co., Ltd.20232—
+6K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+6K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+6K222368Mist ICImagine Milling Technologies, LLC20222—
+6K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+6K221966Dynamic TiBaseTalladium Espana, SL20225—
+6K220482SherlockOpen Implants, LLC20221—
+6K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+6K192742Straumann Variobase CInstitut Straumann AG20211—
+6K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+6K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+6K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+6K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+6K171532TruBase STruabutment, Inc.20187—
+6K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+6K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+6K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+6K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+6K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+7K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+7K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+7K250967SherlockOpen Implants, LLC20250—
+7K243009Mist ICImagine Milling Technologies, LLC20251—
+7K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+7K231559Multi-Unit DAS SystemTalladium España, SL20231—
+7K232271SIMDA abutmentSimda Co., Ltd.20230—
+7K232151Dynamic TiBaseTalladium España, SL20232—
+7K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+7K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+7K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—