510(k) Report

Devices descending from K020646

630 later devices reach Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142167Medentika Abutment SystemMedentika GmbH20157—
+1K110565Abutments for Competitive Implant Systems-Nobel ReplaceBiomet 3i, Inc.201110—
+1K053654Atlantis Abutment for Nobel Replace InterfaceAtlantis Components, Inc.200612—
+1K022424Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102…Nobel Biocare Uas, Inc.2002625—
+2K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+2K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+2K152845Allied Biocompat Abutment for Nobel Replace InterfaceAllied Dental Solutions20160—
+2K111364Haptite Coating Implant SystemDentis Co., Ltd.20121—
+2K112730Abutment for Competitive Implant Straumann Bone Level ConnectionBiomet 3i201292
+2K041661Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc.2004622—
+3K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+3K253341Custom Abutments ASMedentika GmbH20250—
+3K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+3K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+3K181037DIO CAD/CAM AbutmentDio Corporation20187—
+3K173938IS-III HActive FixtureNeobiotech Co., Ltd.20180—
+3K132881Z5CZ-Systems AG20148—
+3K121873Avinent Dental Implant SystemAvinent Implant System S.L.20130—
+3K120776Abutment for Competitive Implant Nobel Active ConnectionBiomet 3i20120—
+3K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+3K073458BT-Tite One (BTICV1), BT-Tite Standard (Btivsm), BT-Tite CV2(BTICV2)Btlock Srl20082—
+3K050406Nobelspeedy ImplantsNobel Biocare AB2005234—
+3K050705Tiunite ImplantsNobel Biocare AB20055321
+3K050258Groovy ImplantsNobel Biocare AB200551128
+3K040757Sic ProSic Invent AG20052—
+4K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+4K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+4K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+4K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+4K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+4K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+4K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+4K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+4K201712Z5-TLZ-Systems AG20200—
+4K200386Z5-BLZ-Systems AG20200—
+4K190243Z5-BLZ-Systems AG20202—
+4K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+4K172668W Zirconia ImplantsTav Medical, Ltd.20184—
+4K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+4K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+4K160119NobelSpeedy GroovyNobel Biocare AB20167—
+4K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+4K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+4K133731Nobelactive Wide Platform (WP)Nobel Biocare AB2014101—
+4K131066Axiom RegAnthogyr Sas20142—
+4K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+4K122988Klockner Dental Implant AbutmentsSoadco, S.L.20139—
+4K123386Periotype X-PertClinical House Europe GmbH20131—
+4K122268Angled Xive MP Abutment, Angled AnkylosDentsply International20122—
+4K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2011180—
+4K101545Genesis Implant SystemKeystone Dental2010153
+4K101207Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2010181—
+4K093630Biodenta Dental Implant SystemBiodenta Swiss AG201018—
+4K093615Spi Dental Implant, ElementThommen Medical AG20101—
+4K091878Osseolink Dental Implant SystemGlobal Implant Solutions, LLC20090—
+4K083869BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S) Dddiii BTICV3, 1, and…Btlock Srl20090—
+4K081101Spectra-System Abutments 2008Implant Direct, LLC200911—
+4K081128Molar ImplantNobel Biocare AB20080—
+4K073622Easy Grip Dental Implant SystemT.F.I. System S.R.L20080—
+4K070184Dental Implant, Dental Abutment, Abutment Screw, Cover Screw, Healing AbutmentOspol AB20081—
+4K062936Nobelperfect Conical ConnectionNobel Biocare AB20061—
+4K062566Nobelreplace Tapered Conical ConnectionNobel Biocare USA, LLC200610927
+4K061410Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant…Zimmer Dental, Inc.20061221
+4K061500Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG20061—
+4K061003SFB & CFB ImplantsNobel Biocare AB2006507—
+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—
+5K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+5K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+5K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K251148JDEvolution Plus L and JDEvolution Plus LEJdentalcare Srl20250—
+5K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+5K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+5K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+5K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+5K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+5K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+5K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+5K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+5K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+5K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+5K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+5K212538DESS Dental ImplantsTerrats Medical SL20211—
+5K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+5K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+5K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+5K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+5K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+5K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+5K193234NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20206—
+5K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+5K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+5K181953SDS1.2 dental implantSds Swiss Dental Solutions AG20191—
+5K191986DESS Dental Smart SolutionsTerrats Medical SL201938—