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
+5K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+5K190552JJ Implant SystemJj Implants20190—
+5K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+5K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+5K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+5K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+5K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+5K173701Implant-One SystemImplant Logistics, Inc.20181—
+5K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+5K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+5K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+5K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+5K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+5K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+5K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+5K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+5K170372SpiralTech Dental Implant SystemSpiraltech Superior Dental Implants, Inc.20178—
+5K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+5K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+5K161416Multi-unit Abutment PlusNobel Biocare AB201774—
+5K153509GPS Angled AbutmentImplant Direct Sybron Manufacturing, LLC20160—
+5K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+5K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+5K1516084plus6Line Abutment SystemOt Medical GmbH20160—
+5K151439Atlantis IsusDentsply International, Inc.20160—
+5K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+5K151916TRI Dental Implant SystemTri Dental Implants Int. AG20154—
+5K143142JDENTALCARE Implant SystemJdentalcare Srl20152—
+5K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+5K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+5K150968TRU Dental Implant SystemSterngold Dental, LLC20150—
+5K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+5K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC20158—
+5K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+5K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+5K133362SGS Dental ImplantSgs International, Ltd.20142—
+5K133050One Plus Implant SystemOsseofuse, Inc.20141—
+5K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+5K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+5K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+5K134045Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant…Zimmer Dental, Inc.201414—
+5K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+5K131748Osseofuse Dental Implant SystemOsseofuse, Inc.20130—
+5K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG201311—
+5K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+5K130221Hero II Dental Implant System, UI Dental Implant SystemMedimecca Co., Ltd.20130—
+5K120776Abutment for Competitive Implant Nobel Active ConnectionBiomet 3i20120—
+5K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+5K111935TI-Base Abutment, 1 Connect AbutmentNt-Trading GmbH and CO KG201264—
+5K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+5K102034Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC20114—
+5K103280Bhdental Implant SystemBhdental, Ltd.20110—
+5K101732Astra Tech Implant SystemAstra Tech AB2011214—
+5K102436Nobel Active 3.0Nobel Biocare AB2010203—
+5K101755Aidi Dental Implant SystemAidi Biomedical, LLC20101—
+5K092261Defcon Tsa/TSH Dental Implant SystemImpladent, S.L.20100—
+5K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB201034—
+5K090081Talladium International Implantology AbutmentsTalladium Espana, SL20100—
+5K093483Atlantis Abutment for Nobel Biocare Active Implant, Atlantis Gemini Abutment, Gemini +…Astra Tech, Inc.200967—
+5K091756Nobelprocera TI AbutmentNobel Biocare AB2009278—
+5K083192Inclusive Titanium Abutment BlanksInclusive Dental Solutions200940—
+5K083205Nobelactive 8.5 MM & 18.0 MMNobel Biocare AB2009103—
+5K083100Goldadapt Non-Engaging Nobelactive NP & RP, Goldadapt Engaging Nobelactive NP & RPNobel Biocare USA, LLC20081—
+5K081806Idi Implant SystemIdi Biomedical, LLC20082—
+5K081078NT/IT SystemOsstem Implant Co., Ltd.20080—
+5K072129Nobelactive Zirconia AbutmentNobel Biocare AB200871—
+5K070533Bti Endosseous Dental Implant Angled AbutmentsB.T.I. Biotechnology Institute, Sl.20070—
+6K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+6K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG20260—
+6K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+6K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K253341Custom Abutments ASMedentika GmbH20250—
+6K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+6K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+6K242064Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20251—
+6K240383Highness Implant SystemHighness Co., Ltd.20240—
+6K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+6K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+6K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+6K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+6K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+6K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNobel Biocare AB20242—
+6K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+6K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+6K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+6K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+6K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—