510(k) Report

Devices descending from K041295

368 later devices reach RN Synocta Ucla Gold Abutment for the Straumann Dental Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K191123Multi-unit AbutmentsMedentika GmbH202011—
+4K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+4K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+4K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+4K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+4K172100URIS OMNI SystemTruabutment, Inc.20187—
+4K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K170080Neodent Implant System - CM Pro PEEK AbutmentJjgc Industria E Comercio DE Materiais Dentarios S.A.20170—
+4K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+4K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+4K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+4K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+4K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+4K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+4K142407Straight Stud AttachmentSterngold Dental, LLC20141—
+4K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+4K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+4K130222Straumann Dental Implant SystemStraumann USA, LLC2013118—
+4K123784Straumann Dental Implant SystemStraumann USA, LLC2013122—
+4K123638Pekkton IvoryCendres & Metaux SA20130—
+4K121585TS Implant SystemOsstem Implant Co., Ltd.201364—
+4K113606NNC Gold Abutment for BridgesStraumann USA20120—
+4K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA2011166—
+4K092814Straumann Dental AbutmentsStraumann Manufacturing, Inc.2009223—
+5K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+5K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K253341Custom Abutments ASMedentika GmbH20250—
+5K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+5K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+5K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+5K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+5K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+5K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+5K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+5K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+5K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+5K232049IS-III active Short ImplantNeobiotech Co., Ltd.20240—
+5K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+5K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+5K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+5K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+5K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+5K222368Mist ICImagine Milling Technologies, LLC20222—
+5K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+5K220823Preat AbutmentsPreat Corporation202216
+5K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+5K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+5K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+5K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+5K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+5K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+5K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+5K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+5K193335SherlockOpen Implants, LLC20203—
+5K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+5K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+5K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+5K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+5K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+5K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+5K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+5K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+5K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+5K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+5K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+5K162390ET Hybrid AbutmentHiossen, Inc.20172—
+5K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+5K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+5K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+5K150250SternSnap Angled AttachmentSterngold Dental, LLC20150—
+5K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+5K140934Hiossen Implant SystemHiossen, Inc.201413—
+5K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+5K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+5K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+5K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+6K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.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—
+6K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+6K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—