510(k) Report

Devices descending from K052070

261 later devices reach Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+7K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+8K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.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—
+8K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+8K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+8K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+8K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+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—
+8K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+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—
+8K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+8K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+8K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+8K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+8K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+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—
+8K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+8K220482SherlockOpen Implants, LLC20221—
+8K220252High Retention Attachment SystemZest Anchors, LLC20221—
+8K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+8K212108Dynamic TiBaseTalladium España, SL20219—
+8K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+8K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+9K261122Mist ICImagine Milling Technologies, LLC20260—
+9K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+9K250967SherlockOpen Implants, LLC20250—
+9K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+9K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+9K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+9K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+9K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+9K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+9K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+9K221673Bonafix TiBaseZentek Medical, LLC20231—
+9K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+10K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+10K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+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—
+11K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+11K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+11K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+11K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+12K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—
+12K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+13K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—