510(k) Report

Devices descending from K925766

565 later devices reach Branemark System Temporary Solutions through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+10K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+10K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+10K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+10K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+10K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+10K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+10K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+10K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+10K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+10K180609Rodo SmilekeyRodo Medical, Inc.20180—
+10K170394Kisses MiniAchimhai Medical Corporation20170—
+10K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+10K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+10K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+11K260940BellaTek BarsZimVie US Corp, LLC20260—
+11K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+11K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+11K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+11K253341Custom Abutments ASMedentika GmbH20250—
+11K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+11K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+11K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+11K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+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—
+12K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+12K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+12K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+12K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+12K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+12K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+12K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+12K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+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—
+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—
+14K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+15K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+16K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—