510(k) Report

Devices descending from K022562

929 later devices reach Various Branemark System Implants-Immediate Function Indication through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNobel Biocare AB20242—
+4K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+4K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+4K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+4K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies20230—
+4K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+4K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+4K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+4K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+4K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+4K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+4K213677Bonafix 2 PlusZentek Medical, LLC20220—
+4K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+4K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+4K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+4K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+4K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+4K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+4K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K220022TRATE Dental Implant SystemTrate AG20221—
+4K213672T3 Pro ImplantsBiomet 3i, LLC20222—
+4K212676Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical)20224—
+4K213599SuperLineDentium Co., Ltd.20220—
+4K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+4K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+4K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+4K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+4K212538DESS Dental ImplantsTerrats Medical SL20211—
+4K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+4K212664SherlockOpen Implants, LLC20212—
+4K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K212108Dynamic TiBaseTalladium España, SL20219—
+4K203554AnyOne External Implant SystemMegagen Implant Co., Ltd.20210—
+4K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+4K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+4K210886MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona20210—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+4K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+4K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+4K193234NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20206—
+4K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+4K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+4K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+4K190919ST Internal Implant SystemT-Plus Implant Tech. Co., Ltd.20200—
+4K181953SDS1.2 dental implantSds Swiss Dental Solutions AG20191—
+4K191201EM SA Implant SystemHiossen, Inc.20191—
+4K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+4K192053W Zirconia ImplantsTav Medical, Ltd.20191—
+4K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+4K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+4K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+4K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+4K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+4K183079Conometric AbutmentsDentsply Sirona, Inc.20190—
+4K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+4K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+4K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+4K180184Zeramex (R) XT Dental Implant System, NobelPearl Dental Implant SystemDentalpoint AG20180—
+4K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+4K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+4K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20186—
+4K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+4K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+4K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+4K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+4K172160Southern Implants PEEK AbutmentsSouthern Implants (Pty), Ltd.20182—
+4K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+4K172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical…Mis Implants Technologies, Ltd.20174—
+4K171466NobelDesign, DTX Studio DesignNobel Biocare AB20170—
+4K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+4K171769Straumann PURE Ceramic ImplantsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20178—
+4K171795Thommen Implant SystemThommen Medical AG20170—
+4K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+4K162633Custom BarsImplant Direct Sybron Manufacturing, LLC20170—
+4K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+4K170849SIMPLANT GuideDentsply Sirona20172—
+4K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+4K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+4K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+4K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+4K163122NobelClinician, DTX Studio implantNobel Biocare AB20172—
+4K161435Temporary Snap AbutmentNobel Biocare AB201601
+4K160786RODO Abutment SystemRodo Medical, Inc.20162—
+4K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+4K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+4K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+4K142846BBX1, BBX2, BBX1MO, BBX1MCGlobaldental, Inc.20160—
+4K152385Zeramex P6 Dental Implant SystemDentalpoint AG20161—
+4K160158NobelProcera HT ML FCZ Implant Bridge and FrameworkNobel Biocare AB20163—
+4K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691