510(k) Report

Devices descending from K965077

674 later devices reach Single Toot Abutment System (Sta or ST Abutment ) for Single Ooth Cement… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+7K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+7K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+7K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+7K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+7K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+7K233083Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical)20242—
+7K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+7K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+7K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+7K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+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—
+7K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies20230—
+7K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+7K221107TRUSTRgorithm Korea20230—
+7K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+7K221488Z7 Zirconia Implant SystemZ7, LLC20230—
+7K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+7K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+7K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+7K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+7K220517IBS SystemInnobiosurg Co., Ltd.20220—
+7K222368Mist ICImagine Milling Technologies, LLC20222—
+7K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+7K220823Preat AbutmentsPreat Corporation202216
+7K221966Dynamic TiBaseTalladium Espana, SL20225—
+7K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+7K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio…Blue Sky Bio, LLC20223—
+7K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+7K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+7K211225MIS Ti-base abutmentDentsply Sirona20210—
+7K202909CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.20210—
+7K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+7K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+7K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+7K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+7K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+7K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+7K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+7K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+7K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+7K193335SherlockOpen Implants, LLC20203—
+7K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+7K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+7K190406SDS2.2 dental implantSds Swiss Dental Solutions AG20200—
+7K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+7K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+7K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+7K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+7K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+7K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+7K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+7K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+7K180609Rodo SmilekeyRodo Medical, Inc.20180—
+7K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+7K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+7K170394Kisses MiniAchimhai Medical Corporation20170—
+7K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+7K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+7K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+7K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+7K162390ET Hybrid AbutmentHiossen, Inc.20172—
+7K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+7K160784CAM Titanium BlanksAltatec GmbH20161—
+7K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+7K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+7K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+7K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+7K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+7K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+7K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+7K113539Revois Pro Implant StsyemRiemser Arzneimittel AG20130—
+7K113042Revois Implant SystemRiemser Arzneimittel AG20130—
+8K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+8K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG20260—
+8K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+8K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+8K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+8K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+8K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+8K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+8K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+8K243009Mist ICImagine Milling Technologies, LLC20251—
+8K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+8K243824Preat AbutmentsPreat Corporation20250—
+8K243278Custom AbutmentsInstitut Straumann AG202501
+8K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+8K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+8K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+8K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+8K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+8K241032BellaTek BarsBiomet 3i, LLC20241—
+8K233389EK Digital AbutmentsHiossen, Inc.20240—
+8K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+8K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+8K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+8K231559Multi-Unit DAS SystemTalladium España, SL20231—
+8K232151Dynamic TiBaseTalladium España, SL20232—