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
+5K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+5K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+5K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+5K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+5K220022TRATE Dental Implant SystemTrate AG20221—
+5K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+5K212664SherlockOpen Implants, LLC20212—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K212108Dynamic TiBaseTalladium España, SL20219—
+5K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+5K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+5K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+5K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+5K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+5K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+5K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+5K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+5K171795Thommen Implant SystemThommen Medical AG20170—
+5K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+5K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+6K261122Mist ICImagine Milling Technologies, LLC20260—
+6K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+6K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+6K240143JDZygoma dental implantsJdentalcare Srl20240—
+6K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+6K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+6K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+6K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+6K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+6K221966Dynamic TiBaseTalladium Espana, SL20225—
+6K220482SherlockOpen Implants, LLC20221—
+6K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+6K201842TruBase STruabutment, Inc.20210—
+6K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+6K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+6K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+6K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+7K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+7K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+7K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+7K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K250967SherlockOpen Implants, LLC20250—
+7K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+7K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+7K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+7K231559Multi-Unit DAS SystemTalladium España, SL20231—
+7K232151Dynamic TiBaseTalladium España, SL20232—
+7K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+7K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+8K243732Multi-Unit DAS SystemTalladium España, SL20260—
+8K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+8K243530Dynamic TiBaseTalladium España, SL20250—
+8K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+8K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+8K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+8K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+8K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+9K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+9K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—