510(k) Report

Devices descending from K032263

476 later devices reach 3I Patient-Specific Dental Abutment and Overdenture Bar through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+6K160784CAM Titanium BlanksAltatec GmbH20161—
+6K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+6K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+6K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+6K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+6K120414Osseospeed PlusAstra Tech AB2012196—
+7K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+7K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+7K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+7K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+7K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+7K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+7K243824Preat AbutmentsPreat Corporation20250—
+7K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+7K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+7K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+7K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+7K241032BellaTek BarsBiomet 3i, LLC20241—
+7K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+7K233389EK Digital AbutmentsHiossen, Inc.20240—
+7K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+7K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+7K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+7K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+7K223663SIMDA AbutmentSimda Co., Ltd.20232—
+7K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+7K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+7K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+7K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+7K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+7K222368Mist ICImagine Milling Technologies, LLC20222—
+7K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+7K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+7K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+7K213599SuperLineDentium Co., Ltd.20220—
+7K212664SherlockOpen Implants, LLC20212—
+7K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+7K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+7K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+7K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+7K192742Straumann Variobase CInstitut Straumann AG20211—
+7K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+7K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+7K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+7K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+7K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+7K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+7K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+7K171532TruBase STruabutment, Inc.20187—
+7K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+7K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+7K170421ET Hybrid AbutmentHiossen, Inc.20180—
+7K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+7K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+7K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+7K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+7K160786RODO Abutment SystemRodo Medical, Inc.20162—
+7K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+7K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+7K150295LOCATOR RTxZest Anchors, Inc.201542—
+7K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+7K142167Medentika Abutment SystemMedentika GmbH20157—
+7K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+8K260940BellaTek BarsZimVie US Corp, LLC20260—
+8K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+8K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+8K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+8K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+8K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+8K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+8K243009Mist ICImagine Milling Technologies, LLC20251—
+8K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+8K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+8K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+8K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+8K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+8K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+8K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+8K232271SIMDA abutmentSimda Co., Ltd.20230—
+8K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+8K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+8K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+8K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+8K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+8K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+8K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+8K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+8K221966Dynamic TiBaseTalladium Espana, SL20225—
+8K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+8K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+8K220482SherlockOpen Implants, LLC20221—
+8K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+8K212108Dynamic TiBaseTalladium España, SL20219—
+8K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+8K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+8K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+8K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+8K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—