510(k) Report

Devices descending from K954512

702 later devices reach Restore Self Tapping Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K192274BV Dental Implant SystemBio Concept Co., Ltd.20200—
+6K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+6K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+6K190406SDS2.2 dental implantSds Swiss Dental Solutions AG20200—
+6K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+6K191123Multi-unit AbutmentsMedentika GmbH202011—
+6K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+6K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+6K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+6K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+6K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+6K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+6K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+6K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+6K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+6K172630Kisses Plus Implant SystemAchimhai Medical Corporation20180—
+6K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+6K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+6K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+6K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+6K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+6K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+6K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+6K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd.201732—
+6K162390ET Hybrid AbutmentHiossen, Inc.20172—
+6K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+6K153521IH Implant SystemSewonmedix, Inc.201610—
+6K160784CAM Titanium BlanksAltatec GmbH20161—
+6K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+6K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+6K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+6K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+6K142813Biogensis Implant System-KissesBiogenesis Co., Ltd.20151—
+6K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+6K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+6K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+6K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+6K131258Saturn Dental ImplantCortex Dental Implants Industries, Ltd.20140—
+6K130808Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA201339—
+6K122192NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary…Straumann USA, LLC20121—
+6K120414Osseospeed PlusAstra Tech AB2012196—
+6K113606NNC Gold Abutment for BridgesStraumann USA20120—
+6K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA2011166—
+6K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+7K260463ZEROS Dental Implant SystemZeros Co., Ltd.20260—
+7K261122Mist ICImagine Milling Technologies, LLC20260—
+7K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+7K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+7K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+7K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+7K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+7K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+7K250280SD TL Implant SystemArum Dentistry Co., Ltd.20250—
+7K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+7K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+7K243278Custom AbutmentsInstitut Straumann AG202501
+7K242753SD TL Implant SystemArum Dentistry Co., Ltd.20251—
+7K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+7K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+7K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+7K241575Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC202401
+7K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+7K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+7K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+7K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+7K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+7K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+7K241032BellaTek BarsBiomet 3i, LLC20241—
+7K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+7K233389EK Digital AbutmentsHiossen, Inc.20240—
+7K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+7K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+7K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+7K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+7K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+7K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+7K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+7K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+7K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+7K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+7K221673Bonafix TiBaseZentek Medical, LLC20231—
+7K222707IH Implant SystemSewonmedix, Inc.20231—
+7K223663SIMDA AbutmentSimda Co., Ltd.20232—
+7K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+7K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+7K222976MU SystemDentis Co., Ltd.20230—
+7K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+7K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+7K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+7K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+7K221966Dynamic TiBaseTalladium Espana, SL20225—
+7K220482SherlockOpen Implants, LLC20221—
+7K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+7K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+7K210039CORE1 Implant SystemCybermed, Inc.20220—
+7K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+7K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+7K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—