510(k) Report

Devices descending from K090069

313 later devices reach Procera Implant Bridge Overdenture through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K182246Mist ICImagine Milling Technologies, LLC20194—
+5K183518Preat AbutmentsPreat Corporation2019223
+5K171532TruBase STruabutment, Inc.20187—
+5K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K170421ET Hybrid AbutmentHiossen, Inc.20180—
+5K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+5K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+5K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+5K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+5K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+5K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+5K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+5K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+6K260940BellaTek BarsZimVie US Corp, LLC20260—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+6K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+6K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+6K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+6K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+6K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+6K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+6K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+6K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+6K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+6K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+6K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.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—
+6K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+6K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+6K222368Mist ICImagine Milling Technologies, LLC20222—
+6K220823Preat AbutmentsPreat Corporation202216
+6K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+6K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+6K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+6K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+6K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+6K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+6K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+6K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+6K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+6K193335SherlockOpen Implants, LLC20203—
+6K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+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—
+6K171795Thommen Implant SystemThommen Medical AG20170—
+6K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+7K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+7K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+7K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+7K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+7K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+7K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+7K243009Mist ICImagine Milling Technologies, LLC20251—
+7K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+7K243824Preat AbutmentsPreat Corporation20250—
+7K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+7K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+7K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+7K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+7K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+7K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+7K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+7K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+7K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+7K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+7K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+7K212664SherlockOpen Implants, LLC20212—
+7K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+7K212108Dynamic TiBaseTalladium España, SL20219—
+7K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+7K201842TruBase STruabutment, Inc.20210—
+8K261122Mist ICImagine Milling Technologies, LLC20260—
+8K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+8K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+8K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+8K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+8K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+8K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+8K221673Bonafix TiBaseZentek Medical, LLC20231—
+8K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+8K221966Dynamic TiBaseTalladium Espana, SL20225—
+8K220482SherlockOpen Implants, LLC20221—
+8K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+9K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+9K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+9K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+9K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—