510(k) Report

Devices descending from K053602

248 later devices reach Procera Software, Model 33145 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+5K192742Straumann Variobase CInstitut Straumann AG20211—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+5K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+5K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+5K191152MIS Ti-base AbutmentDentsply Sirona20201—
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K193335SherlockOpen Implants, LLC20203—
+5K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+5K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+5K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+5K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+5K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+5K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+5K182246Mist ICImagine Milling Technologies, LLC20194—
+5K171532TruBase STruabutment, Inc.20187—
+5K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+5K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+5K170421ET Hybrid AbutmentHiossen, Inc.20180—
+5K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+5K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+5K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+5K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+5K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+5K152555Dental Implant SystemAriabio International, Inc.20160—
+5K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+5K151599iSy Implant SystemAltatec GmbH20150—
+5K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+5K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+5K133362SGS Dental ImplantSgs International, Ltd.20142—
+5K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+6K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+6K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+6K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+6K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+6K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+6K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+6K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+6K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+6K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+6K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+6K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+6K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+6K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+6K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+6K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+6K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+6K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+6K232271SIMDA abutmentSimda Co., Ltd.20230—
+6K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+6K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+6K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+6K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+6K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+6K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+6K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+6K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+6K222368Mist ICImagine Milling Technologies, LLC20222—
+6K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+6K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+6K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+6K220022TRATE Dental Implant SystemTrate AG20221—
+6K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+6K212664SherlockOpen Implants, LLC20212—
+6K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+6K211225MIS Ti-base abutmentDentsply Sirona20210—
+6K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+6K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+6K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+6K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+6K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+6K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+6K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+6K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+6K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+6K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+6K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+6K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+6K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+6K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+7K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+7K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+7K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+7K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+7K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+7K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+7K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+7K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+7K243009Mist ICImagine Milling Technologies, LLC20251—
+7K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+7K240143JDZygoma dental implantsJdentalcare Srl20240—