510(k) Report

Devices descending from K962845

644 later devices reach Replace HA Coated Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+10K232151Dynamic TiBaseTalladium España, SL20232—
+10K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+10K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+10K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+10K223535SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC202301
+10K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+10K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+10K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+10K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+10K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+10K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+10K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+10K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+10K193352AbutmentCADExocad GmbH20210—
+10K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+10K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+10K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+10K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+10K200100Abutment Design3Shape A/S20203—
+10K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+10K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+10K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+10K191152MIS Ti-base AbutmentDentsply Sirona20201—
+10K193078MIS CONNECT Conical Connection SystemDentsply Sirona20200—
+10K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+10K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+10K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+10K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+10K181932DTX Studio designNobel Biocare AB20190—
+10K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+10K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+10K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+10K180609Rodo SmilekeyRodo Medical, Inc.20180—
+10K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+10K170421ET Hybrid AbutmentHiossen, Inc.20180—
+10K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+10K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+10K170394Kisses MiniAchimhai Medical Corporation20170—
+10K170100CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20170—
+10K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+10K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+10K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20171—
+10K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+10K160436CreoDent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20160—
+10K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+10K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+10K151599iSy Implant SystemAltatec GmbH20150—
+10K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+10K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+10K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+10K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+10K130408Era Micro 23 Female Abutment, Era Micro 30 Female AbutmentSterngold Dental, LLC20131—
+11K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+11K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+11K243732Multi-Unit DAS SystemTalladium España, SL20260—
+11K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+11K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+…Dentsply Sirona, Inc.20250—
+11K251297MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20250—
+11K243530Dynamic TiBaseTalladium España, SL20250—
+11K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+11K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+11K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+11K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+11K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+11K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+11K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+11K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+11K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+11K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+11K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+11K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+11K221107TRUSTRgorithm Korea20230—
+11K222636ET Abutment SystemHiossen, Inc.20230—
+11K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+11K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+11K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+11K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+11K213391High Retention Attachment SystemZest Anchors, LLC20227—
+11K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+11K211225MIS Ti-base abutmentDentsply Sirona20210—
+11K202909CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20210—
+11K192742Straumann Variobase CInstitut Straumann AG20211—
+11K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+11K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+11K193404UF (II) Bar holder abutmentDio Corporation20200—
+11K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+11K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+11K171532TruBase STruabutment, Inc.20187—
+11K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+11K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+11K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+11K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+11K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+11K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+11K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+11K160784CAM Titanium BlanksAltatec GmbH20161—
+12K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+12K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+12K252248CEREC Tessera Abutment SystemDentsply Sirona20250—