510(k) Report

Devices descending from K974150

543 later devices reach Procera Preparable Abutment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K213599SuperLineDentium Co., Ltd.20220—
+7K212664SherlockOpen Implants, LLC20212—
+7K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+7K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+7K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+7K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+7K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+7K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+7K192742Straumann Variobase CInstitut Straumann AG20211—
+7K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+7K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+7K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+7K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+7K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+7K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+7K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+7K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+7K171532TruBase STruabutment, Inc.20187—
+7K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+7K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+7K170421ET Hybrid AbutmentHiossen, Inc.20180—
+7K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+7K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+7K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+7K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+7K160786RODO Abutment SystemRodo Medical, Inc.20162—
+7K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+7K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+7K150295LOCATOR RTxZest Anchors, Inc.201542—
+7K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+7K142167Medentika Abutment SystemMedentika GmbH20157—
+7K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+8K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+8K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+8K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+8K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+8K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+8K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+8K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+8K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+8K243009Mist ICImagine Milling Technologies, LLC20251—
+8K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+8K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+8K241032BellaTek BarsBiomet 3i, LLC20241—
+8K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+8K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+8K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+8K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+8K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+8K232271SIMDA abutmentSimda Co., Ltd.20230—
+8K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+8K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+8K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+8K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+8K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+8K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+8K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+8K221966Dynamic TiBaseTalladium Espana, SL20225—
+8K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+8K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+8K220482SherlockOpen Implants, LLC20221—
+8K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+8K212108Dynamic TiBaseTalladium España, SL20219—
+8K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+8K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+8K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+8K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+8K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+8K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+8K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+8K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+8K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+8K180609Rodo SmilekeyRodo Medical, Inc.20180—
+8K170394Kisses MiniAchimhai Medical Corporation20170—
+8K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+8K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+8K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+9K260940BellaTek BarsZimVie US Corp, LLC20260—
+9K261122Mist ICImagine Milling Technologies, LLC20260—
+9K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+9K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+9K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+9K253341Custom Abutments ASMedentika GmbH20250—
+9K250967SherlockOpen Implants, LLC20250—
+9K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+9K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+9K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+9K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+9K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+9K231559Multi-Unit DAS SystemTalladium España, SL20231—
+9K232151Dynamic TiBaseTalladium España, SL20232—
+9K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+9K221673Bonafix TiBaseZentek Medical, LLC20231—
+9K222636ET Abutment SystemHiossen, Inc.20230—
+9K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+9K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+9K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+9K213391High Retention Attachment SystemZest Anchors, LLC20227—
+9K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+9K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—