510(k) Report

Devices descending from K041295

368 later devices reach RN Synocta Ucla Gold Abutment for the Straumann Dental Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+7K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+7K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+7K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+7K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+7K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+7K160784CAM Titanium BlanksAltatec GmbH20161—
+8K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+8K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+8K250967SherlockOpen Implants, LLC20250—
+8K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+8K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+8K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+8K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+8K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+8K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+8K240977DenQ Sub SLA Implant SystemDenq20240—
+8K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+8K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+8K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+8K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+8K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+8K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+8K231559Multi-Unit DAS SystemTalladium España, SL20231—
+8K232151Dynamic TiBaseTalladium España, SL20232—
+8K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+8K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+8K223663SIMDA AbutmentSimda Co., Ltd.20232—
+8K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+8K222976MU SystemDentis Co., Ltd.20230—
+8K220517IBS SystemInnobiosurg Co., Ltd.20220—
+8K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+8K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+8K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+8K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+8K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+8K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+8K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+8K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+8K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+8K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+9K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+9K243732Multi-Unit DAS SystemTalladium España, SL20260—
+9K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+9K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+9K243530Dynamic TiBaseTalladium España, SL20250—
+9K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+9K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+9K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+9K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+9K232271SIMDA abutmentSimda Co., Ltd.20230—
+9K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+9K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+9K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+9K201842TruBase STruabutment, Inc.20210—
+9K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+9K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+9K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+10K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+10K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+10K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+11K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+11K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+11K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+11K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+11K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+12K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+12K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—