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
+1K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+1K111287Astra Tech Implant SystemAstra Tech AB2011201—
+1K101732Astra Tech Implant SystemAstra Tech AB2011214—
+1K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2011180—
+1K101207Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2010181—
+1K080744HG II Fixture SystemOsstem Implant Co., Ltd.2008112—
+1K070184Dental Implant, Dental Abutment, Abutment Screw, Cover Screw, Healing AbutmentOspol AB20081—
+1K072917JJG Evolution Orthodontic Implant SystemOdontit S.A.20080—
+1K071946Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra ImplantsAtlantis Components, Inc.2007209—
+1K070833Atlantis Abutment for Astra ImplantAtlantis Components, Inc.2007357—
+1K061478Procera Titanium Abutment for Astratech and Camlog Implant SystemsNobel Biocare AB200633—
+1K061477Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant SystemsNobel Biocare AB200666—
+2K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+2K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+2K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+2K193234NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20206—
+2K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+2K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+2K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+2K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+2K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+2K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+2K163349MIS V3 Conical Connection Dental Implant System­Mis Implants Technologies, Ltd.20178—
+2K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+2K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+2K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+2K142167Medentika Abutment SystemMedentika GmbH20157—
+2K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+2K142082Zimmer 3.1MM Dental Implant;2.9MM Angled Abutment;Straight Hex, 2.9MM Contour AbutementZimmer Dental, Inc.20140—
+2K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+2K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+2K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+2K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+2K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+2K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+2K130787Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20130—
+2K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+2K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+2K121810Osseospeed Angled Abutment EVAstra Tech AB20138—
+2K120414Osseospeed PlusAstra Tech AB2012196—
+2K112279Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20121—
+2K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc.2011200—
+2K101005Astra Tech Implant System, New ComponentAstra Tech AB2011198—
+2K110356Atlantis Crown Abutment, Atlantis Gemini +(TM) AbutmentAstra Tech, Inc.2011202—
+2K103759Atlantis Abutment in Zirconia for Osseospeed TX Profile ImplantAstra Tech, Inc.201119—
+2K103252Camlog Vario SR AbutmentsAltatec GmbH201132—
+2K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB201034—
+2K090976Vericore Abutment in Zirconia for Implant SystemsWhip-Mix Corp.20091—
+2K090237HG II Fixture SystemHiossen, Inc.200938—
+2K081851Neoss Access AbutmentsNeoss, Ltd.20090—
+2K082213GS Iii Fixture SystemOsstem Implant Co., Ltd.2008110—
+2K081666Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 ImplantsAstra Tech, Inc.2008337—
+2K072241Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc.20077—
+3K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+3K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+3K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+3K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+3K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K250271Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+3K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+3K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+3K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K231566ICX-Implant SystemMedentis Medical GmbH20240—
+3K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+3K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+3K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+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—
+3K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+3K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+3K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+3K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+3K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+3K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+3K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+3K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+3K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+3K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+3K213432MIS Angulated multi-unit abutmentsDentsply Sirona20220—
+3K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+3K213599SuperLineDentium Co., Ltd.20220—
+3K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+3K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+3K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+3K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+3K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+3K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+3K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+3K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+3K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+3K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+3K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+3K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+3K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+3K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+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—