510(k) Report

Devices descending from K050258

511 later devices reach Groovy Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+5K123386Periotype X-PertClinical House Europe GmbH20131—
+5K121810Osseospeed Angled Abutment EVAstra Tech AB20138—
+5K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+5K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc.2011200—
+5K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+5K110171Nobelprocera ZI Abutment Thommen PlatformsNobel Biocare USA, LLC20110—
+6K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+6K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+6K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+6K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K250872Bioline Dental Implant SystemBioline Dental Implant Systems, Ltd.20250—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K250176DAND Dental Implant SystemD.A.N.D. Metal Industries North, Ltd.20250—
+6K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+6K243094Quickdent Dental Implant SystemQuickdent Devices Private, Ltd.20240—
+6K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+6K241692MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20242—
+6K240143JDZygoma dental implantsJdentalcare Srl20240—
+6K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+6K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+6K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+6K233389EK Digital AbutmentsHiossen, Inc.20240—
+6K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+6K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+6K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+6K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+6K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+6K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+6K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+6K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+6K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+6K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+6K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+6K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+6K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K223535SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC202301
+6K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+6K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+6K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+6K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+6K220390CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20220—
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+6K221966Dynamic TiBaseTalladium Espana, SL20225—
+6K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+6K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+6K212664SherlockOpen Implants, LLC20212—
+6K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+6K212108Dynamic TiBaseTalladium España, SL20219—
+6K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+6K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+6K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+6K193352AbutmentCADExocad GmbH20210—
+6K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+6K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+6K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+6K200100Abutment Design3Shape A/S20203—
+6K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+6K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+6K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+6K191152MIS Ti-base AbutmentDentsply Sirona20201—
+6K193078MIS CONNECT Conical Connection SystemDentsply Sirona20200—
+6K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+6K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+6K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+6K181932DTX Studio designNobel Biocare AB20190—
+6K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+6K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+6K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+6K180609Rodo SmilekeyRodo Medical, Inc.20180—
+6K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+6K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+6K170421ET Hybrid AbutmentHiossen, Inc.20180—
+6K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+6K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+6K170394Kisses MiniAchimhai Medical Corporation20170—
+6K170100CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20170—
+6K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+6K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+6K162734CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20171—
+6K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+6K160436CreoDent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20160—
+6K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+6K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+6K151599iSy Implant SystemAltatec GmbH20150—
+6K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+6K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+6K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+6K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+6K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—