510(k) Report

Devices descending from K050406

234 later devices reach Nobelspeedy Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+1K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+1K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+1K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+1K160119NobelSpeedy GroovyNobel Biocare AB20167—
+1K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+1K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+1K133731Nobelactive Wide Platform (WP)Nobel Biocare AB2014101—
+1K131066Axiom RegAnthogyr Sas20142—
+1K121873Avinent Dental Implant SystemAvinent Implant System S.L.20130—
+1K123386Periotype X-PertClinical House Europe GmbH20131—
+1K122268Angled Xive MP Abutment, Angled AnkylosDentsply International20122—
+1K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+1K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2011180—
+1K101207Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2010181—
+1K081128Molar ImplantNobel Biocare AB20080—
+2K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+2K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB20260—
+2K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+2K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+2K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+2K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+2K251148JDEvolution Plus L and JDEvolution Plus LEJdentalcare Srl20250—
+2K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+2K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+2K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+2K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+2K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+2K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+2K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+2K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+2K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+2K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+2K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+2K212538DESS Dental ImplantsTerrats Medical SL20211—
+2K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+2K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+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—
+2K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+2K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+2K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+2K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+2K182246Mist ICImagine Milling Technologies, LLC20194—
+2K183518Preat AbutmentsPreat Corporation2019223
+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—
+2K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+2K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+2K161177Axiom PXAnthogyr Sas20170—
+2K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+2K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+2K161435Temporary Snap AbutmentNobel Biocare AB201601
+2K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+2K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+2K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+2K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+2K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+2K142260NobelActiveNobel Biocare AB201599—
+2K141450AXIOM 2.8Anthogyr Sas201401
+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—
+2K131644Ankylos Syncone Abutment 5(Degree)Dentsply International, Inc.20141—
+2K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+2K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+3K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+3K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+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—
+3K251280DESS® Dental ImplantsTerrats Medical SL20250—
+3K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+3K232383iPhysio® SystemEuroteknika20250—
+3K241462LONGY Implant and LONGY-N ImplantNoris Medical, Ltd.20250—
+3K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+3K233081NUVENTUS NV.C™ Dental Implant SystemInfinitum Eta, Ltd.20240—
+3K231566ICX-Implant SystemMedentis Medical GmbH20240—
+3K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+3K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+3K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+3K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+3K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+3K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+3K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+3K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+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—
+3K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+3K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+3K222368Mist ICImagine Milling Technologies, LLC20222—
+3K220823Preat AbutmentsPreat Corporation202216
+3K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+3K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+3K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—