510(k) Report

Devices descending from K981858

505 later devices reach Atlantis Abutment and Atlantis Abutment Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+7K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+7K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+7K193404UF (II) Bar holder abutmentDio Corporation20200—
+7K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+7K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+7K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+7K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+7K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+7K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+7K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+7K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+7K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+7K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+7K162390ET Hybrid AbutmentHiossen, Inc.20172—
+7K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+7K160784CAM Titanium BlanksAltatec GmbH20161—
+7K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+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—
+8K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+8K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+8K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+8K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+8K243732Multi-Unit DAS SystemTalladium España, SL20260—
+8K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+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—
+8K243009Mist ICImagine Milling Technologies, LLC20251—
+8K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+8K243530Dynamic TiBaseTalladium España, SL20250—
+8K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+8K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+8K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+8K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+8K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.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—
+8K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+8K233389EK Digital AbutmentsHiossen, Inc.20240—
+8K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+8K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+8K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+8K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+8K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+8K223663SIMDA AbutmentSimda Co., Ltd.20232—
+8K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+8K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+8K222976MU SystemDentis Co., Ltd.20230—
+8K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+8K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+8K220482SherlockOpen Implants, LLC20221—
+8K220252High Retention Attachment SystemZest Anchors, LLC20221—
+8K212108Dynamic TiBaseTalladium España, SL20219—
+8K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+8K192742Straumann Variobase CInstitut Straumann AG20211—
+8K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+8K171532TruBase STruabutment, Inc.20187—
+8K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+8K170421ET Hybrid AbutmentHiossen, Inc.20180—
+8K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+8K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+8K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+9K260940BellaTek BarsZimVie US Corp, LLC20260—
+9K261122Mist ICImagine Milling Technologies, LLC20260—
+9K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+9K250967SherlockOpen Implants, LLC20250—
+9K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+9K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+9K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+9K232271SIMDA abutmentSimda Co., Ltd.20230—
+9K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+9K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+9K221673Bonafix TiBaseZentek Medical, LLC20231—
+9K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+9K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+9K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+9K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+9K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+9K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+9K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+10K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+10K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+10K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+10K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+10K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+10K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+10K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+10K201842TruBase STruabutment, Inc.20210—
+11K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+11K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+11K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+11K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+11K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+11K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+11K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+12K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—