510(k) Report

Devices descending from K990342

696 later devices reach Synocta Prosthetics through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+4K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+4K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+4K221488Z7 Zirconia Implant SystemZ7, LLC20230—
+4K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+4K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+4K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+4K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+4K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+4K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+4K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+4K212538DESS Dental ImplantsTerrats Medical SL20211—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+4K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+4K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+4K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+4K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+4K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+4K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+4K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+4K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+4K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+4K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+4K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+4K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+4K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+4K190406SDS2.2 dental implantSds Swiss Dental Solutions AG20200—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+4K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+4K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+4K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+4K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+4K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+4K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+4K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+4K173819MyPlant II Implant SystemHager& Meisinger GmbH20183—
+4K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+4K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+4K172100URIS OMNI SystemTruabutment, Inc.20187—
+4K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+4K172240SPI Dental Implant SystemMsi France20180—
+4K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+4K170421ET Hybrid AbutmentHiossen, Inc.20180—
+4K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+4K170080Neodent Implant System - CM Pro PEEK AbutmentJjgc Industria E Comercio DE Materiais Dentarios S.A.20170—
+4K171795Thommen Implant SystemThommen Medical AG20170—
+4K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+4K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+4K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+4K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+4K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+4K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+4K162073Dental Implants OKTAGON Tissue Level and Bone LevelHager& Meisinger GmbH20170—
+4K160132Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone…Hager& Meisinger GmbH20160—
+4K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+4K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+4K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+4K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+4K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+4K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+4K152555Dental Implant SystemAriabio International, Inc.20160—
+4K151194Klockner Dental Implant Abutments (II)Soadco, S.L.20164—
+4K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+4K151798Inclusive Titanium Abutments compatible with: Straumann synOcta Implant SystemPrismatik Dentalcraft, Inc.20150—
+4K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+4K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+4K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+4K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+4K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+4K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+4K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+4K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+4K150250SternSnap Angled AttachmentSterngold Dental, LLC20150—
+4K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+4K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—