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
+6K200193Kisses Plus Implant SystemAchimhai Medical Corporation20210—
+6K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+6K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+6K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+6K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+6K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+6K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+6K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+6K201553Simply Iconic ImplantsImplant Direct Sybron Manufacturing, LLC20210—
+6K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+6K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+6K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+6K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+6K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+6K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+6K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+6K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+6K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+6K193335SherlockOpen Implants, LLC20203—
+6K190406SDS2.2 dental implantSds Swiss Dental Solutions AG20200—
+6K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+6K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+6K190552JJ Implant SystemJj Implants20190—
+6K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+6K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+6K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+6K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+6K173701Implant-One SystemImplant Logistics, Inc.20181—
+6K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+6K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+6K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+6K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+6K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+6K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+6K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+6K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+6K170372SpiralTech Dental Implant SystemSpiraltech Superior Dental Implants, Inc.20178—
+6K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+6K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+6K161416Multi-unit Abutment PlusNobel Biocare AB201774—
+6K153509GPS Angled AbutmentImplant Direct Sybron Manufacturing, LLC20160—
+6K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+6K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+6K1516084plus6Line Abutment SystemOt Medical GmbH20160—
+6K151439Atlantis IsusDentsply International, Inc.20160—
+6K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+6K151916TRI Dental Implant SystemTri Dental Implants Int. AG20154—
+6K143142JDENTALCARE Implant SystemJdentalcare Srl20152—
+6K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+6K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+6K150968TRU Dental Implant SystemSterngold Dental, LLC20150—
+6K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+6K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC20158—
+6K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+6K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+6K133362SGS Dental ImplantSgs International, Ltd.20142—
+6K133050One Plus Implant SystemOsseofuse, Inc.20141—
+6K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+6K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+6K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+6K134045Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant…Zimmer Dental, Inc.201414—
+6K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+6K131748Osseofuse Dental Implant SystemOsseofuse, Inc.20130—
+6K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG201311—
+6K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+6K130221Hero II Dental Implant System, UI Dental Implant SystemMedimecca Co., Ltd.20130—
+6K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+6K111935TI-Base Abutment, 1 Connect AbutmentNt-Trading GmbH and CO KG201264—
+6K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+6K102034Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC20114—
+6K103280Bhdental Implant SystemBhdental, Ltd.20110—
+6K101732Astra Tech Implant SystemAstra Tech AB2011214—
+6K102436Nobel Active 3.0Nobel Biocare AB2010203—
+6K101755Aidi Dental Implant SystemAidi Biomedical, LLC20101—
+6K092261Defcon Tsa/TSH Dental Implant SystemImpladent, S.L.20100—
+6K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB201034—
+6K090081Talladium International Implantology AbutmentsTalladium Espana, SL20100—
+6K093483Atlantis Abutment for Nobel Biocare Active Implant, Atlantis Gemini Abutment, Gemini +…Astra Tech, Inc.200967—
+6K091756Nobelprocera TI AbutmentNobel Biocare AB2009278—
+6K083192Inclusive Titanium Abutment BlanksInclusive Dental Solutions200940—
+6K083205Nobelactive 8.5 MM & 18.0 MMNobel Biocare AB2009103—
+6K083100Goldadapt Non-Engaging Nobelactive NP & RP, Goldadapt Engaging Nobelactive NP & RPNobel Biocare USA, LLC20081—
+6K081806Idi Implant SystemIdi Biomedical, LLC20082—
+6K081078NT/IT SystemOsstem Implant Co., Ltd.20080—
+6K072129Nobelactive Zirconia AbutmentNobel Biocare AB200871—
+6K070533Bti Endosseous Dental Implant Angled AbutmentsB.T.I. Biotechnology Institute, Sl.20070—
+7K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+7K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+7K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG20260—
+7K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+7K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+7K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+7K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+7K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+7K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+7K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+7K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+7K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+7K243009Mist ICImagine Milling Technologies, LLC20251—
+7K250639DESS Dental Smart SolutionsTerrats Medical SL20250—