510(k) Report

Devices descending from K073075

304 later devices reach Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K261122Mist ICImagine Milling Technologies, LLC20260—
+5K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+5K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+5K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+…Dentsply Sirona, Inc.20250—
+5K251297MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20250—
+5K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+5K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+5K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+5K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+5K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+5K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+5K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+5K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+5K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+5K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+5K231559Multi-Unit DAS SystemTalladium España, SL20231—
+5K232151Dynamic TiBaseTalladium España, SL20232—
+5K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+5K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K221673Bonafix TiBaseZentek Medical, LLC20231—
+5K222636ET Abutment SystemHiossen, Inc.20230—
+5K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+5K220482SherlockOpen Implants, LLC20221—
+5K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+5K213391High Retention Attachment SystemZest Anchors, LLC20227—
+5K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+5K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+5K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+5K191123Multi-unit AbutmentsMedentika GmbH202011—
+5K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+5K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+5K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+5K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+5K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+6K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+6K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+6K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+6K243732Multi-Unit DAS SystemTalladium España, SL20260—
+6K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+6K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+6K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+6K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+6K250967SherlockOpen Implants, LLC20250—
+6K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+6K243530Dynamic TiBaseTalladium España, SL20250—
+6K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+6K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+6K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+6K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+6K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+6K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+6K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+6K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+6K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+6K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+6K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+6K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+6K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+6K222976MU SystemDentis Co., Ltd.20230—
+6K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+6K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+6K220252High Retention Attachment SystemZest Anchors, LLC20221—
+6K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+6K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+6K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+6K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+6K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+6K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+6K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+6K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+6K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+7K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+7K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+7K243278Custom AbutmentsInstitut Straumann AG202501
+7K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+7K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+7K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+7K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+7K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+7K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+7K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+7K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+7K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+7K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+7K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+8K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+8K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+8K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+8K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+8K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+8K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+8K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—