510(k) Report

Devices descending from K050903

251 later devices reach Xawex G 100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K233389EK Digital AbutmentsHiossen, Inc.20240—
+5K240772Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML)Hunan Ceramaster Material Technology Co., Ltd.20240—
+5K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+5K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+5K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+5K231687Gradual Dental Zirconia BlankLiaoning Upcera Co., Ltd.20232—
+5K223663SIMDA AbutmentSimda Co., Ltd.20232—
+5K230003Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankTopzir Biotech Co., Ltd.20230—
+5K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+5K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+5K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+5K222520Zirconia BlockYilink (Tianjin) Biotechnology Co., Ltd.20220—
+5K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+5K221242Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankHunan Vsmile Biotechnology Co., Ltd.20220—
+5K221429KDF Zirconia DiscDenken-Highdental Co., Ltd.20220—
+5K221051Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankChangsha Honchon Technology Co., Ltd.20220—
+5K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+5K213570Dental Zirconia CeramicAidite (Qinhuangdao) Technology Co., Ltd.20220—
+5K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+5K212259Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankZirdent New Material Co., Ltd.20210—
+5K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+5K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+5K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+5K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+5K210097Estar-ZOsstem Implant Co., Ltd.20211—
+5K203590Perfit FS Dental Zirconia Fully Sintered BlockVatech Acucera, Inc.20214—
+5K203499Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blankVatech Acucera, Inc.20210—
+5K203351Perfit ZR HT Dental Zirconia blankVatech Acucera, Inc.20210—
+5K192742Straumann Variobase CInstitut Straumann AG20211—
+5K193055Purzir Dental Zirconia3DBiocad20200—
+5K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+5K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+5K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+5K182246Mist ICImagine Milling Technologies, LLC20194—
+5K183518Preat AbutmentsPreat Corporation2019223
+5K182068Erran Dental ZirconiaHangzhou Erran Technology Co., Ltd.20184—
+5K171532TruBase STruabutment, Inc.20187—
+5K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+5K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+5K170421ET Hybrid AbutmentHiossen, Inc.20180—
+5K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+5K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+5K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+5K160367Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankNissin-Metec China Co., Ltd.20166—
+5K153767X-cera Zirconia BlanksShenzhen Xiangtong Photoelectricity Technology Co., Ltd.20160—
+5K141162All-Ceramic Zirconia BlockRizhao Huge Dental Industry Co., Ltd.20140—
+6K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K253973Gradual Dental Zirconia Blank - GT (F) P1, GT (F) P2, and SP SeriesLiaoning Upcera Co., Ltd.20260—
+6K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+6K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+6K251593DenMat Multilayered Zirconia DiscDenmat Holding, LLC20250—
+6K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+6K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+6K242521Estar-ZEOsstem Implant Co., Ltd.20240—
+6K231566ICX-Implant SystemMedentis Medical GmbH20240—
+6K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+6K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+6K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+6K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+6K232271SIMDA abutmentSimda Co., Ltd.20230—
+6K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+6K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+6K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+6K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+6K222368Mist ICImagine Milling Technologies, LLC20222—
+6K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+6K220823Preat AbutmentsPreat Corporation202216
+6K222686Perfit FS Dental Zirconia Fully Sintered BlockVatech Acucera, Inc.20220—
+6K220816BruxZir NOWPrismatik Dentalcraft, Inc.20222—
+6K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+6K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+6K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+6K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+6K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+6K192262Dental Zirconia BlocksDe Corematrix Co., Ltd.20203—
+6K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+6K193335SherlockOpen Implants, LLC20203—
+6K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+6K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+6K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+6K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+6K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+6K191631ZMAXX Dental Zirconia BlanksZmaxx Bioceramics, LLC20190—
+6K180252Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded BlankCrown Porcelain Dental Technology Co., Ltd.20184—
+7K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+7K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+7K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+7K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+7K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+7K252446BruxZir® NOWPrismatik Dentalcraft, Inc.20250—
+7K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+7K243009Mist ICImagine Milling Technologies, LLC20251—
+7K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+7K243824Preat AbutmentsPreat Corporation20250—
+7K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+7K250223BruxZir® Esthetic NOWPrismatik Dentalcraft, Inc.20250—
+7K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+7K233125Zirconia BlockHangzhou Ivista Medical Devices Co., Ltd.20240—