510(k) Report

Devices descending from K962845

644 later devices reach Replace HA Coated Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+12K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+12K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+12K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+12K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+12K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+12K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+12K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+12K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+12K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+12K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+12K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+12K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+12K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+12K223663SIMDA AbutmentSimda Co., Ltd.20232—
+12K222976MU SystemDentis Co., Ltd.20230—
+12K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+12K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+12K220252High Retention Attachment SystemZest Anchors, LLC20221—
+12K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+12K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+13K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+13K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+13K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+13K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+13K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+13K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+13K232271SIMDA abutmentSimda Co., Ltd.20230—
+13K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+13K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+13K201842TruBase STruabutment, Inc.20210—
+13K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+13K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+13K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+14K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+14K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+14K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+15K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+15K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+15K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+15K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+15K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+16K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—
+16K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—