510(k) Report

Devices descending from K962465

673 later devices reach TIL313 Abutment and Retaining Screw Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K213677Bonafix 2 PlusZentek Medical, LLC20220—
+5K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+5K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+5K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+5K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+5K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+5K220022TRATE Dental Implant SystemTrate AG20221—
+5K213672T3 Pro ImplantsBiomet 3i, LLC20222—
+5K212676Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical)20224—
+5K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+5K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+5K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+5K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+5K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+5K201712Z5-TLZ-Systems AG20200—
+5K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+5K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+5K200386Z5-BLZ-Systems AG20200—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+5K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+5K200355Duranext AbutmentsElegant Dental Corp.20200—
+5K190637Fit & Brilliant Dental Implant SystemF&B Technology Co., Ltd.20200—
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K190919ST Internal Implant SystemT-Plus Implant Tech. Co., Ltd.20200—
+5K190243Z5-BLZ-Systems AG20202—
+5K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+5K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+5K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+5K172668W Zirconia ImplantsTav Medical, Ltd.20184—
+5K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+5K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+5K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+5K172100URIS OMNI SystemTruabutment, Inc.20187—
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+5K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+5K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+5K162633Custom BarsImplant Direct Sybron Manufacturing, LLC20170—
+5K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+5K161435Temporary Snap AbutmentNobel Biocare AB201601
+5K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+5K142846BBX1, BBX2, BBX1MO, BBX1MCGlobaldental, Inc.20160—
+5K1514553Shape Abutment Designer Software3Shape A/S201610—
+5K160483Burn-out Cylinder and Angled Screw AbutmentsDentium Co., Ltd.20160—
+5K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+5K160158NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB20163—
+5K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+5K160119NobelSpeedy GroovyNobel Biocare AB20167—
+5K160244VARIOuniteThommen Medical AG201615—
+5K153779Abutment for BridgesAltatec GmbH20161—
+5K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+5K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+5K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+5K151798Inclusive Titanium Abutments compatible with: Straumann synOcta Implant SystemPrismatik Dentalcraft, Inc.20150—
+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—
+5K150012CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20156—
+5K142260NobelActiveNobel Biocare AB201599—
+5K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+5K142174Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20151—
+5K142167Medentika Abutment SystemMedentika GmbH20157—
+5K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+5K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+5K140934Hiossen Implant SystemHiossen, Inc.201413—
+5K141950HFD100 Rocker Arm AccessoryImris, Inc.20140—
+5K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+5K133991ISYAltatec GmbH20142—
+5K141120Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc.20140—
+5K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+5K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+5K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+5K1330493I T3(R) External Hex Dental ImplantsBiomet 3i201419—
+5K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+5K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—
+5K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+5K123870Xpeed Anyridge Internal Implant SystemMegagen Implant Co., Ltd.20131—
+5K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+5K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+5K112532ET II Bio-SA Fixture SystemHiossen, Inc.201210—
+5K120414Osseospeed PlusAstra Tech AB2012196—
+5K120043CSM Internal-R Implant SystemCsm Implant20121—
+5K110337Universal Maxillary MolarOco Biomedical20121—
+5K110955Anyridge Internal Implant SystemMegagen Co., Ltd.201143—
+5K111216Osseotite 2 Dental ImplantsBiomet 3i, Inc.201121—
+5K112280Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar TitaniumStraumann USA20110—
+5K110778Biodenta Customized AbutmentBiodenta Swiss AG20112—
+5K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+5K110171Nobelprocera ZI Abutment Thommen PlatformsNobel Biocare USA, LLC20110—
+5K103194Intra-Lock Dental Implants with BlossomIntra-Lock International, Inc.20115—
+5K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd.20113—
+5K101225Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant…Promimic AB201118—
+5K102822Implant-One SystemCustom Dental Implants, Inc.20113—
+5K101545Genesis Implant SystemKeystone Dental2010153
+5K100356TDS Precision Dental BarPou YU Biotechnology Co., Ltd.20100—
+5K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc.2010199—
+5K092857Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp.20100—
+5K090054Atlas Implant System - Wide PlusCowellmedi Co., Ltd.20091—