510(k) Report

Devices descending from K871863

550 later devices reach Adbutment Cylinder and Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+4K101714Nobelprocera TI Abutment Thommen PlatformsNobel Biocare AB20101—
+4K093780Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis Gemini +…Astra Tech, Inc.2010200—
+4K091907Nobelprocera Implant Bridge ZirconiaNobel Biocare AB20095—
+4K091920Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace Implants…Astra Tech, Inc.200940—
+4K090976Vericore Abutment in Zirconia for Implant SystemsWhip-Mix Corp.20091—
+4K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions200927—
+4K083871Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment…Astra Tech, Inc.20094—
+4K081748Oneplant Dental Implant SystemWarantec Co., Ltd.20099—
+4K083869BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S) Dddiii BTICV3, 1, and…Btlock Srl20090—
+4K072595Omni-TightBasic Dental Implant Systems, Inc.20081—
+4K072208Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation20074—
+4K063734Atlantis Abutment in Zirconia for 3I Certain InterfaceAtlantis Components, Inc.200738—
+4K061629Certain Prevail Dental ImplantImplant Innovations, Inc.20074—
+4K062277Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc.200671—
+4K053450Atlantis Abutment for Zimmer InterfaceAtlantis Components, Inc.20062—
+5K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+5K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+5K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB20260—
+5K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+5K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic AB20260—
+5K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbH20250—
+5K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+5K251148JDEvolution Plus L and JDEvolution Plus LEJdentalcare Srl20250—
+5K251660T3 Pro Implants– ZimVie Packaging SystemBiomet 3i, LLC20250—
+5K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+5K231566ICX-Implant SystemMedentis Medical GmbH20240—
+5K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+5K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)Pro Med Instruments GmbH20240—
+5K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+5K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+5K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+5K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+5K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+5K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+5K230103Klockner AbutmentsSoadco, S.L.20230—
+5K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+5K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+5K221910QRS Dental Implants SystemQrs Medical, Ltd.20220—
+5K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+5K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+5K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+5K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+5K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+5K211872PiezoImplant SystemRex Implants, Inc.20220—
+5K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+5K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+5K212676Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical)20224—
+5K213599SuperLineDentium Co., Ltd.20220—
+5K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+5K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+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—
+5K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+5K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+5K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+5K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+5K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+5K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+5K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+5K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+5K201712Z5-TLZ-Systems AG20200—
+5K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+5K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+5K200386Z5-BLZ-Systems AG20200—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+5K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+5K200102MIS Dental Implant SystemDentsply Sirona20200—
+5K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+5K200355Duranext AbutmentsElegant Dental Corp.20200—
+5K190637Fit & Brilliant Dental Implant SystemF&B Technology Co., Ltd.20200—
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+5K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+5K190243Z5-BLZ-Systems AG20202—
+5K192149MIS Dental Implant SystemDentsply Sirona, Inc.20191—
+5K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+5K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+5K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+5K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+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—
+5K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+5K182246Mist ICImagine Milling Technologies, LLC20194—
+5K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+5K183518Preat AbutmentsPreat Corporation2019223
+5K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+5K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+5K173701Implant-One SystemImplant Logistics, Inc.20181—