510(k) Report

Devices descending from K894844

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K193352AbutmentCADExocad GmbH20210—
+7K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+7K200100Abutment Design3Shape A/S20203—
+7K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+7K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+7K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+7K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+7K190871Bio-TackS Orthodontic Mini ImplantBiocetec Co., Ltd.20200—
+7K182929BIO-RAY A-1 Anchor Screw SystemMicroware Precision Co., Ltd.20190—
+7K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+7K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+7K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+7K181854OssBuilder SystemOsstem Implant Co., Ltd.20190—
+7K181932DTX Studio designNobel Biocare AB20190—
+7K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+7K180609Rodo SmilekeyRodo Medical, Inc.20180—
+7K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+7K170394Kisses MiniAchimhai Medical Corporation20170—
+7K162633Custom BarsImplant Direct Sybron Manufacturing, LLC20170—
+7K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+7K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+7K153521IH Implant SystemSewonmedix, Inc.201610—
+7K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+7K160158NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB20163—
+7K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+7K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+7K152297OBS Anchorage ScrewBomei Co, Ltd.20161—
+7K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+7K142001Syntec Wetali Orthodontic Mini ScrewsSyntec Scientific Corporation - Taipei Office20151—
+7K132881Z5CZ-Systems AG20148—
+7K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+7K133731Nobelactive Wide Platform (WP)Nobel Biocare AB2014101—
+7K134045Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant…Zimmer Dental, Inc.201414—
+7K113738Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20137—
+7K122602Nobelprocera TI Abutment Camlog PlatformsNobel Biocare AB20130—
+7K113779Conelog Implant SystemAltatec GmbH201214—
+7K120858Implant BarPrismatik Dentalcraft, Inc.20120—
+7K120873Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc.201216—
+7K121334VarioecoThommen Medical AG201216—
+7K110392PSM Lomas / Benefit ScrewsPsm Medical Solutions20115—
+7K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+7K100356TDS Precision Dental BarPou YU Biotechnology Co., Ltd.20100—
+7K101714Nobelprocera TI Abutment Thommen PlatformsNobel Biocare AB20101—
+8K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB20260—
+8K261122Mist ICImagine Milling Technologies, LLC20260—
+8K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+8K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+8K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+8K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+8K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+8K242944Leone Orthodontic Implant TAD (Temporary Anchorage Device)Leone S.P.A.20250—
+8K243278Custom AbutmentsInstitut Straumann AG202501
+8K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+8K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+8K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+8K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+8K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+8K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+8K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+8K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+8K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+8K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+8K231559Multi-Unit DAS SystemTalladium España, SL20231—
+8K232271SIMDA abutmentSimda Co., Ltd.20230—
+8K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+8K232151Dynamic TiBaseTalladium España, SL20232—
+8K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+8K221107TRUSTRgorithm Korea20230—
+8K221673Bonafix TiBaseZentek Medical, LLC20231—
+8K222707IH Implant SystemSewonmedix, Inc.20231—
+8K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+8K222636ET Abutment SystemHiossen, Inc.20230—
+8K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+8K202163Mico One Orthodontic ScrewZe Fang Technology Co., Ltd.20220—
+8K221019Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20223—
+8K220482SherlockOpen Implants, LLC20221—
+8K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+8K213391High Retention Attachment SystemZest Anchors, LLC20227—
+8K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+8K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+8K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+8K201842TruBase STruabutment, Inc.20210—
+8K202278OBS Anchorage Screw, Biokey Anchorage ScrewBomei Co, Ltd.20210—
+8K202452NobelProcera Zirconia Implant BridgeNobel Biocare AB20202—
+8K201712Z5-TLZ-Systems AG20200—
+8K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+8K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+8K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+8K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+8K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+8K190243Z5-BLZ-Systems AG20202—
+8K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+8K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+8K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+8K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+8K161335Dual Top Screw SystemJeil Medical Corporation20173—
+8K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+8K161435Temporary Snap AbutmentNobel Biocare AB201601
+8K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+8K153779Abutment for BridgesAltatec GmbH20161—