510(k) Report

Devices descending from K111357

222 later devices reach Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+4K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+4K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+4K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+4K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+4K222368Mist ICImagine Milling Technologies, LLC20222—
+4K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+4K220823Preat AbutmentsPreat Corporation202216
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+4K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+4K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+4K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+4K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+4K200355Duranext AbutmentsElegant Dental Corp.20200—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K193335SherlockOpen Implants, LLC20203—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+4K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+4K181037DIO CAD/CAM AbutmentDio Corporation20187—
+4K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+4K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+4K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+4K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+4K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+4K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+4K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+4K162390ET Hybrid AbutmentHiossen, Inc.20172—
+4K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+4K160784CAM Titanium BlanksAltatec GmbH20161—
+4K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+4K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+4K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+4K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+5K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+5K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+5K243009Mist ICImagine Milling Technologies, LLC20251—
+5K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K243824Preat AbutmentsPreat Corporation20250—
+5K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+5K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+5K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+5K233389EK Digital AbutmentsHiossen, Inc.20240—
+5K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+5K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+5K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+5K223663SIMDA AbutmentSimda Co., Ltd.20232—
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+5K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+5K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+5K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+5K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+5K212664SherlockOpen Implants, LLC20212—
+5K212108Dynamic TiBaseTalladium España, SL20219—
+5K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+5K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+5K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K192742Straumann Variobase CInstitut Straumann AG20211—
+5K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+5K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+5K171532TruBase STruabutment, Inc.20187—
+5K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+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—
+6K261122Mist ICImagine Milling Technologies, LLC20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+6K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+6K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+6K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+6K232271SIMDA abutmentSimda Co., Ltd.20230—
+6K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+6K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+6K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+6K221966Dynamic TiBaseTalladium Espana, SL20225—
+6K220482SherlockOpen Implants, LLC20221—
+6K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+6K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+6K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+6K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+6K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—