510(k) Report

Devices descending from K061003

507 later devices reach SFB & CFB Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K232383iPhysio® SystemEuroteknika20250—
+5K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+5K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+5K243094Quickdent Dental Implant SystemQuickdent Devices Private, Ltd.20240—
+5K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K241692MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20242—
+5K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+5K240143JDZygoma dental implantsJdentalcare Srl20240—
+5K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+5K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+5K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+5K233389EK Digital AbutmentsHiossen, Inc.20240—
+5K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+5K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+5K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+5K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+5K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+5K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+5K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+5K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+5K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+5K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+5K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+5K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+5K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+5K222368Mist ICImagine Milling Technologies, LLC20222—
+5K221966Dynamic TiBaseTalladium Espana, SL20225—
+5K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+5K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+5K212664SherlockOpen Implants, LLC20212—
+5K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K212108Dynamic TiBaseTalladium España, SL20219—
+5K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+5K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+5K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+5K193352AbutmentCADExocad GmbH20210—
+5K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+5K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+5K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+5K200100Abutment Design3Shape A/S20203—
+5K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+5K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+5K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+5K191152MIS Ti-base AbutmentDentsply Sirona20201—
+5K193078MIS CONNECT Conical Connection SystemDentsply Sirona20200—
+5K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+5K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20191—
+5K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+5K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+5K181932DTX Studio designNobel Biocare AB20190—
+5K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+5K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+5K180609Rodo SmilekeyRodo Medical, Inc.20180—
+5K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K170421ET Hybrid AbutmentHiossen, Inc.20180—
+5K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+5K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+5K170394Kisses MiniAchimhai Medical Corporation20170—
+5K170100CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20170—
+5K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+5K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+5K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20171—
+5K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+5K160436CreoDent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20160—
+5K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+5K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+5K151599iSy Implant SystemAltatec GmbH20150—
+5K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+5K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+5K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+5K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+5K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+5K130408Era Micro 23 Female Abutment, Era Micro 30 Female AbutmentSterngold Dental, LLC20131—
+6K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+6K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+…Dentsply Sirona, Inc.20250—
+6K251297MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20250—
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+6K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—