510(k) Report

Devices descending from K053384

528 later devices reach Fixature Microthread Osseospeed, a Component of the Astra Tech Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+3K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+3K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+3K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+3K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+3K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+3K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+3K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+3K182246Mist ICImagine Milling Technologies, LLC20194—
+3K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+3K183518Preat AbutmentsPreat Corporation2019223
+3K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+3K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+3K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+3K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+3K173326MIS CONNECT Conical Connection AbutmentMis Implants Technologies, Ltd.20181—
+3K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+3K172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical…Mis Implants Technologies, Ltd.20174—
+3K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+3K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+3K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+3K171795Thommen Implant SystemThommen Medical AG20170—
+3K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+3K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+3K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+3K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+3K160786RODO Abutment SystemRodo Medical, Inc.20162—
+3K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+3K160244VARIOuniteThommen Medical AG201615—
+3K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+3K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+3K152555Dental Implant SystemAriabio International, Inc.20160—
+3K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+3K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+3K150040ImplanovaDental Evolutions, Inc.20150—
+3K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+3K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+3K150295LOCATOR RTxZest Anchors, Inc.201542—
+3K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+3K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+3K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+3K133362SGS Dental ImplantSgs International, Ltd.20142—
+3K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+3K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+3K133991ISYAltatec GmbH20142—
+3K123471Etii SA Fixture SystemHiossen, Inc.201314—
+3K130408Era Micro 23 Female Abutment, Era Micro 30 Female AbutmentSterngold Dental, LLC20131—
+3K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—
+3K120089Biogenesis Implant SystemBiogenesis Co., Ltd.20130—
+3K113779Conelog Implant SystemAltatec GmbH201214—
+3K121995TS Fixture SystemOsstem Implant Co., Ltd.201224—
+3K121334VarioecoThommen Medical AG201216—
+3K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+3K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+3K110778Biodenta Customized AbutmentBiodenta Swiss AG20112—
+3K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd.20113—
+3K100993Inclusive Titanium Abutments for Astra Tech Osseospeed ImplantsPrismatik Dentalcraft, Inc.201033—
+3K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+3K092857Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp.20100—
+3K091208GS Iii SystemOsstem Implant Co., Ltd.201028—
+3K093352HG Iii Fixture SystemHiossen, Inc.2009105—
+4K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+4K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+4K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+4K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+4K253341Custom Abutments ASMedentika GmbH20250—
+4K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+4K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+4K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+4K232383iPhysio® SystemEuroteknika20250—
+4K241692MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20242—
+4K240143JDZygoma dental implantsJdentalcare Srl20240—
+4K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+4K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+4K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+4K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+4K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+4K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+4K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+4K232268STERI-OSS Implant SystemZeros Co., Ltd.20241—
+4K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+4K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+4K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+4K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+4K222778Osstem Implant SystemOsstem Implant Co., Ltd.20232—
+4K222738Point implant systemPointnix Co., Ltd.20230—
+4K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+4K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+4K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+4K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+4K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—