510(k) Report

Devices descending from K894844

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K053099Biohorizons Plastic Temporary AbutmentsBioHorizons Implant Systems, Inc.20061—
+3K060062Straumann OrthosystemInstitut Straumann AG200612
+3K042965Tomas PinDentaurum, Inc.200526—
+3K040757Sic ProSic Invent AG20052—
+3K033984Straumann Dental Implant SystemInstitut Straumann AG2004376—
+3K041295RN Synocta Ucla Gold Abutment for the Straumann Dental ImplantInstitut Straumann AG2004368—
+3K040469The Straumann Ortho Implant SystemThe Straumann Co.20042—
+3K040205Intra-Lock International Angled Prosthetic AbutmentsIntra-Lock International20040—
+3K033767Dual Top Anchor System ScrewsJeil Medical Corporation200454—
+3K031936Osteomed Orthodontic Screw SystemOsteomed LP200463—
+3K033243Iti Synocta Meso AbutmentsStraumann USA2003514—
+3K032302Xive TG AbutmentsFriadent GmbH200395—
+3K032498Dental Implant Coping (Prosthetic Accessories to the Iti Dental Implant System)Straumann USA20031—
+3K013891Synocta Angled Abutments for the Iti Wide Neck ImplantInstitut Straumann AG20022—
+4K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+4K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+4K253341Custom Abutments ASMedentika GmbH20250—
+4K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+4K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+4K232383iPhysio® SystemEuroteknika20250—
+4K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+4K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+4K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+4K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+4K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+4K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+4K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+4K193234NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20206—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K191123Multi-unit AbutmentsMedentika GmbH202011—
+4K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+4K181953SDS1.2 dental implantSds Swiss Dental Solutions AG20191—
+4K192053W Zirconia ImplantsTav Medical, Ltd.20191—
+4K190048UF (II) Anatomic abutmentDio Corporation20190—
+4K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+4K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+4K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+4K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+4K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+4K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+4K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+4K172240SPI Dental Implant SystemMsi France20180—
+4K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+4K172798Straumann CARES Abutments CoCrInstitut Straumann AG20180—
+4K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+4K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+4K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+4K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+4K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+4K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+4K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+4K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+4K162390ET Hybrid AbutmentHiossen, Inc.20172—
+4K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+4K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+4K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+4K151590Straumann RN Gold Abutment for BridgeStraumann USA, LLC20160—
+4K152555Dental Implant SystemAriabio International, Inc.20160—
+4K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+4K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+4K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+4K143539Dental Implant OKTAGON Bone LevelHager& Meisinger GmbH20158—
+4K142751Chang Gung ComMed Series Dental Implant SystemChang Gung Medical Technology Co., Ltd.20150—
+4K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+4K150250SternSnap Angled AttachmentSterngold Dental, LLC20150—
+4K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+4K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+4K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+4K142667Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC…Sterngold Dental, LLC20150—
+4K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+4K141211Inclusive Titanium Abutments Compatible with Straumann Tissue Level ImplantsPrismatik Dentalcraft, Inc.20141—
+4K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+4K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+4K141120Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc.20140—
+4K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+4K132214Abutment RP, Abutment WP, Burn-Out Coping, Screws, Titanium Adhesive Base, Alligator…Hager& Meisinger GmbH20149—
+4K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+4K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+4K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+4K131701Z5MLB, Z5MLCZ-Systems AG20131—
+4K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+4K131101Itero SoftwareCadent, Ltd. an Align Technology Company20130—
+4K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+4K122988Klockner Dental Implant AbutmentsSoadco, S.L.20139—
+4K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+4K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+4K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—