510(k) Report

Devices descending from K101945

180 later devices reach Neodent Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+1K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+1K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+1K193234NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20206—
+1K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+1K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+1K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+1K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+1K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+1K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+1K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+1K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+1K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+1K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+2K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+2K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+2K250271Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+2K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+2K231566ICX-Implant SystemMedentis Medical GmbH20240—
+2K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+2K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+2K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+2K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+2K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+2K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+2K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+2K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+2K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+2K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+2K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+2K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+2K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+2K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+2K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+2K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+2K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+2K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+2K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+2K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+2K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+2K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+2K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+2K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+2K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+2K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+2K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+2K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+2K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+2K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+2K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+2K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+2K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+2K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+3K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+3K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+3K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+3K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+3K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+3K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+3K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+3K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+3K232383iPhysio® SystemEuroteknika20250—
+3K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+3K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+3K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+3K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+3K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+3K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+3K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+3K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+3K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+3K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+3K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+3K191123Multi-unit AbutmentsMedentika GmbH202011—
+3K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+3K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+3K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+3K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+3K182246Mist ICImagine Milling Technologies, LLC20194—
+3K183518Preat AbutmentsPreat Corporation2019223
+3K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+3K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+3K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+3K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+3K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+4K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+4K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+4K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+4K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+4K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+4K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+4K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+4K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+4K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+4K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—