510(k) Report

Devices descending from K944964

633 later devices reach Branemark System Miruscone Abutment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+9K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+9K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+9K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+9K121117NDX AbutmentsNational Dentex Corp20120—
+9K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc.2012197—
+9K112280Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar TitaniumStraumann USA20110—
+10K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+10K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+10K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+10K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+10K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+10K251280DESS® Dental ImplantsTerrats Medical SL20250—
+10K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+10K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+10K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+10K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+10K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+10K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+10K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+10K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+10K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+10K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+10K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+10K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+10K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+10K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+10K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+10K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+10K221107TRUSTRgorithm Korea20230—
+10K221488Z7 Zirconia Implant SystemZ7, LLC20230—
+10K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+10K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+10K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+10K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+10K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+10K220823Preat AbutmentsPreat Corporation202216
+10K221019Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20223—
+10K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+10K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+10K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+10K211225MIS Ti-base abutmentDentsply Sirona20210—
+10K202909CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20210—
+10K202452NobelProcera Zirconia Implant BridgeNobel Biocare AB20202—
+10K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+10K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+10K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+10K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+10K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+10K193335SherlockOpen Implants, LLC20203—
+10K190406SDS2.2 dental implantSds Swiss Dental Solutions AG20200—
+10K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+10K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+10K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+10K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+10K182246Mist ICImagine Milling Technologies, LLC20194—
+10K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+10K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+10K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+10K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+10K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+10K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+10K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+10K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+10K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+10K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+10K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+10K162390ET Hybrid AbutmentHiossen, Inc.20172—
+10K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+10K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+10K160784CAM Titanium BlanksAltatec GmbH20161—
+10K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+10K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+10K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+10K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+10K120414Osseospeed PlusAstra Tech AB2012196—
+11K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+11K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+11K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+11K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+11K243824Preat AbutmentsPreat Corporation20250—
+11K240346NobelProcera Zirconia Implant BridgeNobel Biocare AB20250—
+11K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+11K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+11K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+11K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+11K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+11K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+11K233389EK Digital AbutmentsHiossen, Inc.20240—
+11K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+11K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+11K233083Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20242—
+11K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+11K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+11K223663SIMDA AbutmentSimda Co., Ltd.20232—
+11K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+11K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+11K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+11K222368Mist ICImagine Milling Technologies, LLC20222—
+11K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—