510(k) Report

Devices descending from K961737

550 later devices reach Cera One Abutment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K222636ET Abutment SystemHiossen, Inc.20230—
+11K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+11K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+11K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+11K213391High Retention Attachment SystemZest Anchors, LLC20227—
+11K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+11K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+11K201842TruBase STruabutment, Inc.20210—
+11K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+11K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+11K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+12K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+12K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+12K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+12K243732Multi-Unit DAS SystemTalladium España, SL20260—
+12K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+12K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+12K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+12K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+12K243530Dynamic TiBaseTalladium España, SL20250—
+12K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+12K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+12K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+12K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+12K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+12K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+12K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+12K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+12K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+12K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+12K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+12K222976MU SystemDentis Co., Ltd.20230—
+12K220252High Retention Attachment SystemZest Anchors, LLC20221—
+12K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+12K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+12K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+13K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+13K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+13K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+13K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+13K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+13K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+13K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+13K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+14K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+14K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+14K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+14K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+15K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+16K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—