510(k) Report

Devices descending from K010185

234 later devices reach 6.0 X 5.7MM Dental Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+4K181138IS-III active SystemNeobiotech Co., Ltd.201823—
+4K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+4K173938IS-III HActive FixtureNeobiotech Co., Ltd.20180—
+4K172354OssBuilder SystemOsstem Implant Co., Ltd.20183—
+4K171297AR_N Type Implant SystemBiotem Co., Ltd.20181—
+4K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+4K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+4K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+4K140600SB AnchorOsstem Implant Co., Ltd.20144—
+4K130840Smartbuilder System (SB1)Osstem Implant Co., Ltd.20130—
+4K123988Anyonetm Internal Implant SystemMegagen Implant Co., Ltd.201319—
+4K123870Xpeed Anyridge Internal Implant SystemMegagen Implant Co., Ltd.20131—
+4K120503Cmi Implant IS II ActiveNeobiotech Co., Ltd.20129—
+4K090377Sinus Quick EB SystemNeobiotech Co., Ltd.20090—
+5K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+5K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+5K232383iPhysio® SystemEuroteknika20250—
+5K243278Custom AbutmentsInstitut Straumann AG202501
+5K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+5K242261Accelx Implant SystemBiotech Dental, LLC20240—
+5K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+5K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+5K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+5K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+5K223924LW Implant SystemOssvis Co., Ltd.20231—
+5K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+5K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+5K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+5K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+5K222451Save GBRDentis Co., Ltd.20230—
+5K220517IBS SystemInnobiosurg Co., Ltd.20220—
+5K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+5K222368Mist ICImagine Milling Technologies, LLC20222—
+5K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+5K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+5K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+5K220823Preat AbutmentsPreat Corporation202216
+5K210354SNUCONE Bone Level Implant SystemSnucone Co., Ltd.20220—
+5K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+5K213506NB 1 SA Implant SystemArum Dentistry Co., Ltd.20225—
+5K213599SuperLineDentium Co., Ltd.20220—
+5K210499Alpha Dent Implants Dental Implants SystemAlpha Dent Implants GmbH20211—
+5K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+5K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+5K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+5K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+5K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+5K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+5K192294I DoI DO Biotech Co., Ltd.20200—
+5K192747Yxoss CBR®Reoss GmbH20200—
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+5K193335SherlockOpen Implants, LLC20203—
+5K190641AR_N SLA Type Implant SystemBiotem Co., Ltd.20200—
+5K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+5K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+5K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+5K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+5K181854OssBuilder SystemOsstem Implant Co., Ltd.20190—
+5K172100URIS OMNI SystemTruabutment, Inc.20187—
+5K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+5K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+6K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K250280SD TL Implant SystemArum Dentistry Co., Ltd.20250—
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+6K241703SD Implant SystemArum Dentistry Co., Ltd.20250—
+6K240435Alpha Dent Implants Dental Implants SystemAlpha Dent Implants GmbH20240—
+6K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+6K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+6K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+6K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+6K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—