510(k) Report

Devices descending from K062129

434 later devices reach P.0004 Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K122192NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary…Straumann USA, LLC20121—
+2K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+2K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA2011222—
+2K110580Narrow Connection Straumann Anatomic Ips E.Max AbutmentsStraumann USA20110—
+2K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+2K100779Sustain Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20102—
+2K092261Defcon Tsa/TSH Dental Implant SystemImpladent, S.L.20100—
+2K093027Straumann RC Temporary AbutmentsStraumann USA201097—
+2K093113Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG2009169—
+2K092814Straumann Dental AbutmentsStraumann Manufacturing, Inc.2009223—
+2K081005P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG20082631
+2K080286Cementable Abuntments; Temporary Copings; Protective CapsStraumann USA2008179—
+3K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+3K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+3K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+3K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K253341Custom Abutments ASMedentika GmbH20250—
+3K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+3K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+3K251280DESS® Dental ImplantsTerrats Medical SL20250—
+3K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+3K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+3K232383iPhysio® SystemEuroteknika20250—
+3K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+3K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+3K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+3K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+3K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+3K232049IS-III active Short ImplantNeobiotech Co., Ltd.20240—
+3K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+3K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+3K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+3K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+3K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+3K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+3K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+3K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+3K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+3K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+3K230103Klockner AbutmentsSoadco, S.L.20230—
+3K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+3K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+3K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+3K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+3K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+3K222368Mist ICImagine Milling Technologies, LLC20222—
+3K220823Preat AbutmentsPreat Corporation202216
+3K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+3K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+3K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+3K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+3K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+3K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+3K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+3K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+3K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+3K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+3K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+3K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+3K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+3K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+3K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+3K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+3K191152MIS Ti-base AbutmentDentsply Sirona20201—
+3K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+3K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+3K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+3K193335SherlockOpen Implants, LLC20203—
+3K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+3K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+3K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+3K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+3K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+3K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+3K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+3K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+3K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+3K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+3K172100URIS OMNI SystemTruabutment, Inc.20187—
+3K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+3K172798Straumann CARES Abutments CoCrInstitut Straumann AG20180—
+3K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+3K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+3K170080Neodent Implant System - CM Pro PEEK AbutmentJjgc Industria E Comercio DE Materiais Dentarios S.A.20170—
+3K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+3K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017382
+3K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+3K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+3K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+3K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+3K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+3K152555Dental Implant SystemAriabio International, Inc.20160—
+3K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+3K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+3K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+3K151798Inclusive Titanium Abutments compatible with: Straumann synOcta Implant SystemPrismatik Dentalcraft, Inc.20150—
+3K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+3K151599iSy Implant SystemAltatec GmbH20150—
+3K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—