510(k) Report

Devices descending from K011028

184 later devices reach Screw-Vent Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+4K222368Mist ICImagine Milling Technologies, LLC20222—
+4K220823Preat AbutmentsPreat Corporation202216
+4K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+4K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+4K220022TRATE Dental Implant SystemTrate AG20221—
+4K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+4K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K193335SherlockOpen Implants, LLC20203—
+4K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+4K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+4K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+4K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20186—
+4K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+4K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+4K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+4K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+4K121117NDX AbutmentsNational Dentex Corp20120—
+5K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+5K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+5K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K243009Mist ICImagine Milling Technologies, LLC20251—
+5K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K243824Preat AbutmentsPreat Corporation20250—
+5K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+5K240143JDZygoma dental implantsJdentalcare Srl20240—
+5K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+5K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) 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—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+5K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+5K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+5K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+5K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+5K212664SherlockOpen Implants, LLC20212—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K212108Dynamic TiBaseTalladium España, SL20219—
+5K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+5K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20191—
+5K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+6K261122Mist ICImagine Milling Technologies, LLC20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+6K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+6K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+6K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+6K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+6K223535SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC202301
+6K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+6K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+6K221966Dynamic TiBaseTalladium Espana, SL20225—
+6K220482SherlockOpen Implants, LLC20221—
+6K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+7K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+7K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+7K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+7K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K250967SherlockOpen Implants, LLC20250—
+7K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+7K231559Multi-Unit DAS SystemTalladium España, SL20231—
+7K232151Dynamic TiBaseTalladium España, SL20232—
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+8K243732Multi-Unit DAS SystemTalladium España, SL20260—
+8K243530Dynamic TiBaseTalladium España, SL20250—
+8K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+9K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—