510(k) Report

Devices descending from K994376

665 later devices reach Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+7K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+7K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+7K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+7K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+7K221673Bonafix TiBaseZentek Medical, LLC20231—
+7K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+7K222976MU SystemDentis Co., Ltd.20230—
+7K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+7K220482SherlockOpen Implants, LLC20221—
+7K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+7K220252High Retention Attachment SystemZest Anchors, LLC20221—
+7K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+7K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+7K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+7K193352AbutmentCADExocad GmbH20210—
+7K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+7K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+7K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+7K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+7K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+7K200100Abutment Design3Shape A/S20203—
+7K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+7K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+7K200355Duranext AbutmentsElegant Dental Corp.20200—
+7K191152MIS Ti-base AbutmentDentsply Sirona20201—
+7K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+7K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+7K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+7K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+7K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+7K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+7K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+7K181932DTX Studio designNobel Biocare AB20190—
+7K170732Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20180—
+7K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+7K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+7K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+7K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+7K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+7K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+7K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+7K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+7K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+7K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+7K162390ET Hybrid AbutmentHiossen, Inc.20172—
+7K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+7K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+7K160784CAM Titanium BlanksAltatec GmbH20161—
+7K160213s-Clean Tapered II RBM Implant SystemDentis Co., Ltd.20160—
+7K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+7K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+7K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+7K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+7K150344Dentis Dental Implant SystemDentis Co., Ltd.201520—
+7K140091Xpeed Anyridge Internal Implant SysyemMegagen Implant Co., Ltd.20149—
+7K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+7K130408Era Micro 23 Female Abutment, Era Micro 30 Female AbutmentSterngold Dental, LLC20131—
+7K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG201311—
+7K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+7K122231Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd.201225—
+7K090377Sinus Quick EB SystemNeobiotech Co., Ltd.20090—
+8K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+8K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+8K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+8K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+8K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+8K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+8K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+8K250967SherlockOpen Implants, LLC20250—
+8K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+8K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+8K242030MegaGen Dental Implant AbutmentMegagen Implant Co., Ltd.20250—
+8K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+8K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+8K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+8K240383Highness Implant SystemHighness Co., Ltd.20240—
+8K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+8K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+8K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+8K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+8K233389EK Digital AbutmentsHiossen, Inc.20240—
+8K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+8K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+8K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+8K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+8K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+8K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+8K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+8K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+8K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+8K221107TRUSTRgorithm Korea20230—
+8K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+8K223663SIMDA AbutmentSimda Co., Ltd.20232—
+8K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+8K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+8K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+8K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—