510(k) Report

Devices descending from K081005

263 later devices reach P.004 NC Cares Titanium and Ceramic Abutments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+3K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+3K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+3K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+3K112280Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar TitaniumStraumann USA20110—
+4K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+4K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+4K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+4K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+4K232383iPhysio® SystemEuroteknika20250—
+4K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+4K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+4K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+4K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+4K233389EK Digital AbutmentsHiossen, Inc.20240—
+4K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+4K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+4K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+4K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+4K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+4K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+4K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+4K221107TRUSTRgorithm Korea20230—
+4K223663SIMDA AbutmentSimda Co., Ltd.20232—
+4K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+4K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+4K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+4K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+4K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+4K222368Mist ICImagine Milling Technologies, LLC20222—
+4K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+4K220823Preat AbutmentsPreat Corporation202216
+4K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+4K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+4K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+4K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+4K211225MIS Ti-base abutmentDentsply Sirona20210—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+4K192742Straumann Variobase CInstitut Straumann AG20211—
+4K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K193335SherlockOpen Implants, LLC20203—
+4K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+4K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+4K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+4K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+4K171532TruBase STruabutment, Inc.20187—
+4K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+4K170421ET Hybrid AbutmentHiossen, Inc.20180—
+4K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+4K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+4K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+4K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+4K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+4K152555Dental Implant SystemAriabio International, Inc.20160—
+4K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+4K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+4K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+4K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+4K133362SGS Dental ImplantSgs International, Ltd.20142—
+4K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+5K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+5K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+5K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+5K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K243009Mist ICImagine Milling Technologies, LLC20251—
+5K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K243824Preat AbutmentsPreat Corporation20250—
+5K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+5K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+5K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+5K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+5K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+5K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K232271SIMDA abutmentSimda Co., Ltd.20230—
+5K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+5K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+5K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+5K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+5K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—