510(k) Report

Devices descending from K022424

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111364Haptite Coating Implant SystemDentis Co., Ltd.20121—
+1K041661Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc.2004622—
+2K173938IS-III HActive FixtureNeobiotech Co., Ltd.20180—
+2K132881Z5CZ-Systems AG20148—
+2K121873Avinent Dental Implant SystemAvinent Implant System S.L.20130—
+2K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+2K073458BT-Tite One (BTICV1), BT-Tite Standard (Btivsm), BT-Tite CV2(BTICV2)Btlock Srl20082—
+2K050406Nobelspeedy ImplantsNobel Biocare AB2005234—
+2K050705Tiunite ImplantsNobel Biocare AB20055321
+2K050258Groovy ImplantsNobel Biocare AB200551128
+2K040757Sic ProSic Invent AG20052—
+3K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+3K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+3K201712Z5-TLZ-Systems AG20200—
+3K200386Z5-BLZ-Systems AG20200—
+3K190243Z5-BLZ-Systems AG20202—
+3K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+3K172668W Zirconia ImplantsTav Medical, Ltd.20184—
+3K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+3K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+3K160119NobelSpeedy GroovyNobel Biocare AB20167—
+3K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+3K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+3K133731Nobelactive Wide Platform (WP)Nobel Biocare AB2014101—
+3K131066Axiom RegAnthogyr Sas20142—
+3K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+3K122988Klockner Dental Implant AbutmentsSoadco, S.L.20139—
+3K123386Periotype X-PertClinical House Europe GmbH20131—
+3K122268Angled Xive MP Abutment, Angled AnkylosDentsply International20122—
+3K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2011180—
+3K101545Genesis Implant SystemKeystone Dental2010153
+3K101207Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2010181—
+3K093630Biodenta Dental Implant SystemBiodenta Swiss AG201018—
+3K093615Spi Dental Implant, ElementThommen Medical AG20101—
+3K091878Osseolink Dental Implant SystemGlobal Implant Solutions, LLC20090—
+3K083869BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S) Dddiii BTICV3, 1, and…Btlock Srl20090—
+3K081101Spectra-System Abutments 2008Implant Direct, LLC200911—
+3K081128Molar ImplantNobel Biocare AB20080—
+3K073622Easy Grip Dental Implant SystemT.F.I. System S.R.L20080—
+3K070184Dental Implant, Dental Abutment, Abutment Screw, Cover Screw, Healing AbutmentOspol AB20081—
+3K062936Nobelperfect Conical ConnectionNobel Biocare AB20061—
+3K062566Nobelreplace Tapered Conical ConnectionNobel Biocare USA, LLC200610927
+3K061410Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant…Zimmer Dental, Inc.20061221
+3K061500Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG20061—
+3K061003SFB & CFB ImplantsNobel Biocare AB2006507—
+4K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+4K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB20260—
+4K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+4K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+4K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K251148JDEvolution Plus L and JDEvolution Plus LEJdentalcare Srl20250—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+4K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+4K212538DESS Dental ImplantsTerrats Medical SL20211—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+4K193234NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20206—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K181953SDS1.2 dental implantSds Swiss Dental Solutions AG20191—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+4K192053W Zirconia ImplantsTav Medical, Ltd.20191—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+4K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+4K171795Thommen Implant SystemThommen Medical AG20170—
+4K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+4K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+4K161177Axiom PXAnthogyr Sas20170—
+4K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+4K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+4K161435Temporary Snap AbutmentNobel Biocare AB201601
+4K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+4K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+4K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+4K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+4K151194Klockner Dental Implant Abutments (II)Soadco, S.L.20164—
+4K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+4K151928PUR Dental Implant SystemSterngold Dental, LLC20150—
+4K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—