510(k) Report

Devices descending from K993595

942 later devices reach Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+5K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+5K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+5K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+5K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+5K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+5K171795Thommen Implant SystemThommen Medical AG20170—
+5K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+5K162633Custom BarsImplant Direct Sybron Manufacturing, LLC20170—
+5K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+5K161177Axiom PXAnthogyr Sas20170—
+5K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+5K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+5K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+5K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+5K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+5K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+5K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+5K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+5K161435Temporary Snap AbutmentNobel Biocare AB201601
+5K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+5K153521IH Implant SystemSewonmedix, Inc.201610—
+5K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+5K153509GPS Angled AbutmentImplant Direct Sybron Manufacturing, LLC20160—
+5K160158NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB20163—
+5K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+5K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+5K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+5K151194Klockner Dental Implant Abutments (II)Soadco, S.L.20164—
+5K152520Magicore SystemInnobiosurg Co., Ltd.20167—
+5K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+5K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+5K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+5K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+5K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+5K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+5K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+5K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+5K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+5K142260NobelActiveNobel Biocare AB201599—
+5K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+5K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+5K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+5K141450AXIOM 2.8Anthogyr Sas201401
+5K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+5K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+5K130694JR Implant SystemLK Consulting Group USA, Inc.20140—
+5K132956U Fit Dental Implant SystemT Strong, Inc.20141—
+5K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+5K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+5K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+5K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+5K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+5K131644Ankylos Syncone Abutment 5(Degree)Dentsply International, Inc.20141—
+5K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC2013104
+5K113738Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20137—
+5K131097LEGACY3 6MM Length ImplantsImplant Direct Sybron Manufacturing, LLC20130—
+5K123988Anyonetm Internal Implant SystemMegagen Implant Co., Ltd.201319—
+5K131345Tiarray Dental Implant SystemNasseo, Inc.20130—
+5K122804Royal-Dent Eureka Dental Implant SystemIntai Technology Corp.20130—
+5K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+5K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+5K122602Nobelprocera TI Abutment Camlog PlatformsNobel Biocare AB20130—
+5K113779Conelog Implant SystemAltatec GmbH201214—
+5K121843NP-Cast Abutment SystemOsstem Implant Co., Ltd.201254—
+5K120858Implant BarPrismatik Dentalcraft, Inc.20120—
+5K121334VarioecoThommen Medical AG201216—
+5K120847ET/SS Implant SystemOsstem Implant Co., Ltd.201275—
+5K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+5K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+5K110308Prosthetic SystemOsstem Implant Co., Ltd.2011105—
+5K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+5K110778Biodenta Customized AbutmentBiodenta Swiss AG20112—
+5K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd.20113—
+5K103537ET Iii SA Ultra Wide SystemHiossen, Inc.201137—
+5K101890Ball Abutment SystemMegagen Co., Ltd.20110—
+5K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+5K100356TDS Precision Dental BarPou YU Biotechnology Co., Ltd.20100—
+5K101714Nobelprocera TI Abutment Thommen PlatformsNobel Biocare AB20101—
+5K100245HS/HG Prosthetic SystemOsstem Implant Co., Ltd.2010111—
+5K100511Cotec Dental Implant SystemCotec Implant Co., Ltd.20100—
+5K093889Modification to: HG Iii Ultra Wide SystemHiossen, Inc.201038—
+5K090825SQ IS SystemNeobiotech Co., Ltd.200955—
+5K082843Modificaton to: Dentis Dental Implant SystemDentis Co., Ltd.20091—
+5K083633HS II Short Fixture SystemOsstem Implant Co., Ltd.200976—
+5K081786Ziocera & Convertible SystemOsstem Implant Co., Ltd.2008123—
+5K083141Simpact Endosseous Dental Implant SystemSimpact, LLC20080—
+5K080744HG II Fixture SystemOsstem Implant Co., Ltd.2008112—
+5K073142Nobelreplace Hexagonal ImplantNobel Biocare USA, LLC2008952
+5K072570Nobelactive Multi Unit AbutmentNobel Biocare AB20071811
+5K072980Nobelperfect Conical Connection Hexagonal ImplantsNobel Biocare AB20070—
+5K072896GS Fixture SystemOsstem Implant Co., Ltd.200715—
+5K071370Nobelactive Internal Connection ImplantNobel Biocare AB20074144
+5K063718SFB and CFB Implants - 5.0 PlatformNobel Biocare AB20070—
+5K062749SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP, Model…Nobel Biocare AB2006327—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+6K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+6K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—