510(k) Report

Devices descending from K990342

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+5K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+5K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+5K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+5K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+5K200386Z5-BLZ-Systems AG20200—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+5K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+5K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+5K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+5K200355Duranext AbutmentsElegant Dental Corp.20200—
+5K191152MIS Ti-base AbutmentDentsply Sirona20201—
+5K193335SherlockOpen Implants, LLC20203—
+5K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+5K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+5K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+5K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+5K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+5K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+5K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+5K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+5K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+5K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+5K181037DIO CAD/CAM AbutmentDio Corporation20187—
+5K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+5K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+5K171532TruBase STruabutment, Inc.20187—
+5K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+5K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+5K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+5K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+5K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+5K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+5K162848Straumann CARES Golden Ti/TiN AbutmentsInstitut Straumann AG20170—
+5K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+5K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+5K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+5K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+5K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+5K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+5K160786RODO Abutment SystemRodo Medical, Inc.20162—
+5K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+5K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+5K160784CAM Titanium BlanksAltatec GmbH20161—
+5K1514553Shape Abutment Designer Software3Shape A/S201610—
+5K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+5K160244VARIOuniteThommen Medical AG201615—
+5K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+5K151439Atlantis IsusDentsply International, Inc.20160—
+5K151599iSy Implant SystemAltatec GmbH20150—
+5K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+5K150295LOCATOR RTxZest Anchors, Inc.201542—
+5K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+5K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+5K140934Hiossen Implant SystemHiossen, Inc.201413—
+5K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+5K132749Nobelprocera Overdenture BarNobel Biocare USA, LLC20140—
+5K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+5K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+5K122424Isus Implant SuprastructuresDentsply International, Inc.201313—
+5K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+5K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+5K120271Artisan Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20120—
+5K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+5K113606NNC Gold Abutment for BridgesStraumann USA20120—
+5K113410NNC Solid Abutment NNC Temporary Coping for Colid Abutment NNC Temporary Cap for Colid…Straumann USA20121—
+5K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+5K110259Architex Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20111—
+5K103252Camlog Vario SR AbutmentsAltatec GmbH201132—
+5K093630Biodenta Dental Implant SystemBiodenta Swiss AG201018—
+5K091848Nobel/Procera Implant BridgeNobel Biocare AB20091—
+5K091907Nobelprocera Implant Bridge ZirconiaNobel Biocare AB20095—
+5K091904Nobelprocera ZI AbutmentNobel Biocare AB200935—
+5K091756Nobelprocera TI AbutmentNobel Biocare AB2009278—
+6K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+6K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+6K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+6K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+6K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+6K240143JDZygoma dental implantsJdentalcare Srl20240—
+6K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+6K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+6K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+6K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+6K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+6K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—