510(k) Report

Devices descending from K894844

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K092814Straumann Dental AbutmentsStraumann Manufacturing, Inc.2009223—
+5K091390HDC Sterile Self Ligating Spider Screw, Model Sli,SL2Hdc S.R.L.20090—
+5K090069Procera Implant Bridge OverdentureNobel Biocare AB2009313—
+5K083869BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S) Dddiii BTICV3, 1, and…Btlock Srl20090—
+5K081419Straumann Dental Implant SystemInstitut Straumann AG2009142—
+5K082764Straumann WN Cares Titanium AbutmentInstitut Straumann AG2008171—
+5K073217Inclusive Implant AbutmentsInclusive Dental Solutions20083—
+5K080286Cementable Abuntments; Temporary Copings; Protective CapsStraumann USA2008179—
+5K071490Leone Orthodontic Mini ImplantLeone S.P.A.200814—
+5K080074Ace Surigical Tru-Fix Implant System, Model 454-180X-XXAce Surgical Supply Co., Inc.20085—
+5K052968Modification to: Orlus Mini ScrewOrtholution Co., Ltd.20062—
+5K060958Straumann Narrow Neck ImplantsStraumann USA2006228—
+5K061529Procera Zirconia Abutment for Camlog Implant SystemNobel Biocare AB200626—
+5K061478Procera Titanium Abutment for Astratech and Camlog Implant SystemsNobel Biocare AB200633—
+5K053091Procera Implant Bridge ZirconiaNobel Biocare AB20066—
+5K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004327—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+6K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K251569Bone ScrewOsstem Implant Co., Ltd.20250—
+6K251280DESS® Dental ImplantsTerrats Medical SL20250—
+6K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+6K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+6K240143JDZygoma dental implantsJdentalcare Srl20240—
+6K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+6K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+6K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+6K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+6K232049IS-III active Short ImplantNeobiotech Co., Ltd.20240—
+6K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+6K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+6K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+6K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+6K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+6K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+6K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+6K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+6K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+6K230103Klockner AbutmentsSoadco, S.L.20230—
+6K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+6K222367Save GBRDentis Co., Ltd.20230—
+6K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+6K222368Mist ICImagine Milling Technologies, LLC20222—
+6K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+6K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+6K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+6K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+6K220823Preat AbutmentsPreat Corporation202216
+6K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+6K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K213599SuperLineDentium Co., Ltd.20220—
+6K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+6K211992Ortho MI SystemOsteonic Co., Ltd.20210—
+6K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+6K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+6K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+6K192742Straumann Variobase CInstitut Straumann AG20211—
+6K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+6K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+6K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+6K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+6K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+6K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+6K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+6K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+6K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+6K200355Duranext AbutmentsElegant Dental Corp.20200—
+6K191152MIS Ti-base AbutmentDentsply Sirona20201—
+6K193335SherlockOpen Implants, LLC20203—
+6K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+6K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+6K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+6K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+6K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+6K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+6K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+6K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+6K181037DIO CAD/CAM AbutmentDio Corporation20187—
+6K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+6K171532TruBase STruabutment, Inc.20187—
+6K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+6K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+6K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+6K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+6K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+6K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+6K162848Straumann CARES Golden Ti/TiN AbutmentsInstitut Straumann AG20170—
+6K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+6K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+6K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—