510(k) Report

Devices descending from K943720

760 later devices reach Iti Transversal Screwing System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K041236Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004328—
+5K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+5K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K260268OrthoEasy Pal; OrthoEasy Pal Long NeckBernhard Förster GmbH (Bernhard Foerster Ltd.)20260—
+5K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+5K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+5K253341Custom Abutments ASMedentika GmbH20250—
+5K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+5K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K250271Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+5K241183ISO AbutmentSeum Medi Co., Ltd.20250—
+5K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+5K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+5K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+5K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+5K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+5K231566ICX-Implant SystemMedentis Medical GmbH20240—
+5K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+5K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+5K233389EK Digital AbutmentsHiossen, Inc.20240—
+5K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+5K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+5K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+5K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+5K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+5K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+5K221488Z7 Zirconia Implant SystemZ7, LLC20230—
+5K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+5K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+5K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+5K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+5K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+5K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+5K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+5K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+5K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+5K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+5K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+5K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+5K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+5K212538DESS Dental ImplantsTerrats Medical SL20211—
+5K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+5K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+5K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+5K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+5K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+5K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+5K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+5K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+5K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+5K201919Blue Sky Bio TADBlue Sky Bio, LLC20200—
+5K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+5K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+5K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+5K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+5K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+5K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+5K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+5K190406SDS2.2 dental implantSds Swiss Dental Solutions AG20200—
+5K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+5K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+5K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+5K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+5K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+5K182881Bone Screw, Bone TackOsstem Implant Co., Ltd.20191—
+5K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+5K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+5K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+5K182246Mist ICImagine Milling Technologies, LLC20194—
+5K183518Preat AbutmentsPreat Corporation2019223
+5K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+5K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+5K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+5K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+5K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+5K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+5K173819MyPlant II Implant SystemHager& Meisinger GmbH20183—
+5K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+5K170697GBR systemSurgident20182—
+5K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+5K172100URIS OMNI SystemTruabutment, Inc.20187—
+5K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+5K172240SPI Dental Implant SystemMsi France20180—
+5K171784Straumann Dental Implant SystemStraumann USA, LLC20184—