510(k) Report

Devices descending from K161416

74 later devices reach Multi-unit Abutment Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+1K242064Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20251—
+1K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+1K221381KDG AbutmentsKeystone Dental, Inc.20220—
+1K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+1K200193Kisses Plus Implant SystemAchimhai Medical Corporation20210—
+1K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+1K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+1K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+1K183518Preat AbutmentsPreat Corporation2019223
+2K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+2K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB20260—
+2K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+2K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+2K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+2K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+2K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+2K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+2K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+2K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+2K220823Preat AbutmentsPreat Corporation202216
+2K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+2K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+2K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+2K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+2K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+2K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+2K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+2K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+2K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+2K193335SherlockOpen Implants, LLC20203—
+3K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+3K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+3K243824Preat AbutmentsPreat Corporation20250—
+3K232383iPhysio® SystemEuroteknika20250—
+3K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+3K231566ICX-Implant SystemMedentis Medical GmbH20240—
+3K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+3K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+3K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+3K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+3K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+3K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+3K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+3K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+3K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+3K212664SherlockOpen Implants, LLC20212—
+3K212108Dynamic TiBaseTalladium España, SL20219—
+4K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+4K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+4K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+4K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+4K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+4K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+4K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+4K221673Bonafix TiBaseZentek Medical, LLC20231—
+4K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+4K221966Dynamic TiBaseTalladium Espana, SL20225—
+4K220482SherlockOpen Implants, LLC20221—
+5K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+5K250967SherlockOpen Implants, LLC20250—
+5K231559Multi-Unit DAS SystemTalladium España, SL20231—
+5K232151Dynamic TiBaseTalladium España, SL20232—
+5K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K243732Multi-Unit DAS SystemTalladium España, SL20260—
+6K243530Dynamic TiBaseTalladium España, SL20250—
+6K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—