510(k) Report

Devices descending from K944964

633 later devices reach Branemark System Miruscone Abutment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+11K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+11K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+11K212664SherlockOpen Implants, LLC20212—
+11K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+11K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+11K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+11K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+11K192742Straumann Variobase CInstitut Straumann AG20211—
+11K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+11K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+11K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+11K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+11K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+11K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+11K171532TruBase STruabutment, Inc.20187—
+11K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+11K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+11K170421ET Hybrid AbutmentHiossen, Inc.20180—
+11K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+11K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+11K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+11K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+11K160786RODO Abutment SystemRodo Medical, Inc.20162—
+11K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+11K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+11K150295LOCATOR RTxZest Anchors, Inc.201542—
+11K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+11K142167Medentika Abutment SystemMedentika GmbH20157—
+11K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+12K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+12K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+12K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+12K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+12K243009Mist ICImagine Milling Technologies, LLC20251—
+12K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+12K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+12K241032BellaTek BarsBiomet 3i, LLC20241—
+12K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+12K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+12K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+12K232271SIMDA abutmentSimda Co., Ltd.20230—
+12K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+12K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+12K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+12K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+12K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+12K221966Dynamic TiBaseTalladium Espana, SL20225—
+12K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+12K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+12K220482SherlockOpen Implants, LLC20221—
+12K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+12K212108Dynamic TiBaseTalladium España, SL20219—
+12K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+12K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+12K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+12K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+12K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+12K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+12K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+12K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+12K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+12K180609Rodo SmilekeyRodo Medical, Inc.20180—
+12K170394Kisses MiniAchimhai Medical Corporation20170—
+12K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+12K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+12K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+13K260940BellaTek BarsZimVie US Corp, LLC20260—
+13K261122Mist ICImagine Milling Technologies, LLC20260—
+13K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+13K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+13K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+13K253341Custom Abutments ASMedentika GmbH20250—
+13K250967SherlockOpen Implants, LLC20250—
+13K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+13K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+13K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+13K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+13K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+13K231559Multi-Unit DAS SystemTalladium España, SL20231—
+13K232151Dynamic TiBaseTalladium España, SL20232—
+13K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+13K221673Bonafix TiBaseZentek Medical, LLC20231—
+13K222636ET Abutment SystemHiossen, Inc.20230—
+13K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+13K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+13K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+13K213391High Retention Attachment SystemZest Anchors, LLC20227—
+13K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+13K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+13K201842TruBase STruabutment, Inc.20210—
+13K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+13K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+13K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+14K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+14K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+14K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+14K243732Multi-Unit DAS SystemTalladium España, SL20260—
+14K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+14K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—