510(k) Report

Devices descending from K072151

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+6K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+6K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+6K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+6K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+6K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+6K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+6K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+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—
+6K212108Dynamic TiBaseTalladium España, SL20219—
+6K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+6K201842TruBase STruabutment, Inc.20210—
+6K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+6K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+6K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+6K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+6K171795Thommen Implant SystemThommen Medical AG20170—
+6K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+6K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+7K261122Mist ICImagine Milling Technologies, LLC20260—
+7K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+7K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+7K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+7K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+7K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+7K240143JDZygoma dental implantsJdentalcare Srl20240—
+7K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+7K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+7K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+7K221673Bonafix TiBaseZentek Medical, LLC20231—
+7K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+7K221966Dynamic TiBaseTalladium Espana, SL20225—
+7K220482SherlockOpen Implants, LLC20221—
+7K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+7K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+7K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+7K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+7K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+8K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+8K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+8K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+8K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+8K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+8K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+8K250967SherlockOpen Implants, LLC20250—
+8K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+8K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+8K231559Multi-Unit DAS SystemTalladium España, SL20231—
+8K232151Dynamic TiBaseTalladium España, SL20232—
+8K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+8K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+9K243732Multi-Unit DAS SystemTalladium España, SL20260—
+9K243530Dynamic TiBaseTalladium España, SL20250—
+9K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+9K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+9K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+9K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+10K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—