510(k) Report

Devices descending from K894844

764 later devices reach Bonefit Implant System Accessories & Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K220022TRATE Dental Implant SystemTrate AG20221—
+5K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+5K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+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—
+5K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+5K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+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—
+5K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+5K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+5K201919Blue Sky Bio TADBlue Sky Bio, LLC20200—
+5K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+5K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+5K200386Z5-BLZ-Systems AG20200—
+5K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+5K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+5K190406SDS2.2 dental implantSds Swiss Dental Solutions AG20200—
+5K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+5K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+5K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+5K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+5K182881Bone Screw, Bone TackOsstem Implant Co., Ltd.20191—
+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—
+5K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+5K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+5K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+5K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+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—
+5K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+5K170421ET Hybrid AbutmentHiossen, Inc.20180—
+5K170080Neodent Implant System - CM Pro PEEK AbutmentJjgc Industria E Comercio DE Materiais Dentarios S.A.20170—
+5K171795Thommen Implant SystemThommen Medical AG20170—
+5K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+5K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+5K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+5K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+5K162073Dental Implants OKTAGON Tissue Level and Bone LevelHager& Meisinger GmbH20170—
+5K160132Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone…Hager& Meisinger GmbH20160—
+5K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+5K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+5K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+5K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+5K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+5K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+5K151194Klockner Dental Implant Abutments (II)Soadco, S.L.20164—
+5K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+5K151798Inclusive Titanium Abutments compatible with: Straumann synOcta Implant SystemPrismatik Dentalcraft, Inc.20150—
+5K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+5K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+5K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+5K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+5K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+5K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+5K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+5K143730GBR SystemJeil Medical Corporation20152—
+5K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+5K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+5K141923Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/XPrismatik Dentalcraft, Inc.20150—
+5K142118Inclusive Titanium Abutments Compatible with: Straumann Bone Level, Nobel Biocare BranaePrismatik Dentalcraft, Inc.20142—
+5K133991ISYAltatec GmbH20142—
+5K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+5K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+5K132144KeratorLK Consulting Group USA, Inc.20140—
+5K131258Saturn Dental ImplantCortex Dental Implants Industries, Ltd.20140—
+5K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+5K131526Sfi-BarCendres & Metaux SA20130—
+5K122069Storm Mini ScrewLancer Orthodontics, Inc.20130—
+5K123638Pekkton IvoryCendres & Metaux SA20130—
+5K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+5K121585TS Implant SystemOsstem Implant Co., Ltd.201364—
+5K121117NDX AbutmentsNational Dentex Corp20120—
+5K120414Osseospeed PlusAstra Tech AB2012196—
+5K112280Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar TitaniumStraumann USA20110—
+5K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+5K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA2011222—
+5K110580Narrow Connection Straumann Anatomic Ips E.Max AbutmentsStraumann USA20110—
+5K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+5K102804Spi Titanium Base for Cad/CamThommen Medical AG201183—
+5K103105Orthodontic ScrewOsstem Implant Co., Ltd.20114—
+5K102769Neodent Implant for Orthodontic AnchorageJjgc Industria E Comercio DE Materiais Dentarios S20110—
+5K100779Sustain Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20102—
+5K101545Genesis Implant SystemKeystone Dental2010153
+5K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—