510(k) Report

Devices descending from K042658

441 later devices reach Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+8K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+9K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+9K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+9K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+9K243732Multi-Unit DAS SystemTalladium España, SL20260—
+9K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+9K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+9K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+9K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+9K243530Dynamic TiBaseTalladium España, SL20250—
+9K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+9K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+9K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+9K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+9K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+9K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+9K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+9K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+9K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+9K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+9K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+9K222976MU SystemDentis Co., Ltd.20230—
+9K220252High Retention Attachment SystemZest Anchors, LLC20221—
+9K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+9K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+9K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+10K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+10K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+10K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+10K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+10K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+10K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+10K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+10K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+11K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+11K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+11K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+11K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+12K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+13K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—