510(k) Report

Devices descending from K062129

434 later devices reach P.0004 Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+6K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+6K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+6K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+6K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+6K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+6K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+6K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+6K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+6K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+6K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+6K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+7K243732Multi-Unit DAS SystemTalladium España, SL20260—
+7K243530Dynamic TiBaseTalladium España, SL20250—
+7K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+7K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+7K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+7K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+7K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+7K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+7K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+7K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+7K201842TruBase STruabutment, Inc.20210—
+7K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+7K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+8K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+8K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+8K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+8K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+8K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+9K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+9K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+9K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—