510(k) Report

Devices descending from K050903

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081253Zirdent Cad/Cam BlocksC5 Medical Werks, Inc.20081—
+1K073568PSL Biozir BlockP.S.L. International, Inc.20080—
+1K072569Metoxit Cam-BlanksMetoxit AG2007186—
+1K062695Sagemax Z-BlankSagemax Bioceramics, Inc.200676—
+1K061804Zerion Alpha, ; Zerion BetaEtkon International GmbH2006171—
+2K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+2K173971K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucentYeti Dentalprodukte GmbH20180—
+2K130991Nexxzr (TM)T and Nexxzr (TM)SSagemax Bioceramics, Inc.20147—
+2K130198Neo Denta ZirconiaNeo Group Limited20130—
+2K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+2K093748DD Bio Z and DD Bio Z - TranspaDental Direkt of Amerika UG (Haftungsbeschraenkt)201013—
+2K092630ZIROXZencera, Inc.20091—
+2K091362Ceramic Pedatric Preformed CrownEz-Pedo, Inc.20090—
+2K082137DLMS-ZirblocksDental Milling Laboratory Supplies (Dlms)20090—
+2K083201Zmatch BlockDentaim Co., Ltd.20091—
+2K082652Bittar Zirconia BlocksBittar Zirconia Block, LLC20080—
+2K081850Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc.200843—
+2K081263StarceramH.C. Starck Ceramics GmbH & Co.Kg200817—
+2K080195Nacera Z and Nacera Z MediumDoceram Medical Ceramics GmbH2008167—
+2K070045Zirblank-PS and Zirblank-FSAcucera, Inc.20072—
+3K2108841Derful HS, 1Derful HT1derful, Inc.20210—
+3K193090HCG Zirconia Ceramic BlockHocheng Corporation20200—
+3K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+3K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+3K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+3K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+3K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+3K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+3K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+3K143071Nacera PearlDoceram Medical Ceramics GmbH20150—
+3K150196DD cubeX2Dental Direkt GmbH20159—
+3K142987DD Bio Z, DD Bio ZX (square), DD BioZX (square) colorDental Direkt of Amerika UG (Haftungsbeschraenkt)20157—
+3K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+3K142043Insync ZR High Translucency ZirconiaJensen Industries, Inc.20140—
+3K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+3K133213StarceramH.C. Starck Ceramics GmbH20133—
+3K120852Zirconia Blanks (Zircostar)Kerox, Ltd.20120—
+3K100250XceramXceramusa20100—
+3K093571ZR Dental BlockAms Co., Ltd.20100—
+3K093560Upcera Zirconia BlanksShenyang Upcera Co., Ltd.201041—
+3K091852Bisque Zirconia Blanks, Model R610191, R610210, R610211, R610205Refractron Technologies Corp.20090—
+4K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+4K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+4K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+4K241579DD Hybridlayer (multicolored zirconia)Dental Direkt GmbH20240—
+4K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+4K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+4K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+4K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+4K202673X-cera Pre-shaded Zirconia BlanksDongguan Xiangtong Co., Ltd.20200—
+4K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+4K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+4K200355Duranext AbutmentsElegant Dental Corp.20200—
+4K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+4K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+4K181037DIO CAD/CAM AbutmentDio Corporation20187—
+4K171585LUXEN Zr, LUXEN SmileDentalmax Co., Ltd.20185—
+4K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+4K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+4K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+4K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+4K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+4K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+4K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+4K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+4K163238Eclipse Kiss ZirconiaAms20170—
+4K162390ET Hybrid AbutmentHiossen, Inc.20172—
+4K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+4K160203Adamant Zirconia DiscAdamant Co., Ltd.20160—
+4K160784CAM Titanium BlanksAltatec GmbH20161—
+4K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+4K152175Upcera Dental Zirconia Blank for Aesthetic RestorationLiaoning Upcera Co., Ltd.20154—
+4K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+4K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+4K143656StarCeram® Z-Nature, StarCeram® Z-SmileH.C. Starck Ceramics GmbH20150—
+4K141724Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankLiaoning Upcera Co., Ltd.201425—
+4K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+4K140924StarceramH.C. Starck Ceramics GmbH20141—
+4K122972CDC Zirconia BlanksContinental Dental Ceramics, Inc. (Dba Continental20120—
+4K111291Aidite Zirconia Dental CeramicsQinhuangdao Aidite High-Technical Ceramics Co, Ltd.20117—
+5K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+5K262074Any-ZircosMediclus Co., Ltd.20260—
+5K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.20260—
+5K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+5K232383iPhysio® SystemEuroteknika20250—
+5K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+5K241151Luxen 5GDentalmax Co., Ltd.20241—
+5K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+5K241602Kingcera Dental Zirconia BlankHunan Qinghao Puzhong Technology Co., Ltd.20240—
+5K240672Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT…Zhejiang Zahndent Biotechnology Co., Ltd.20240—
+5K240912Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)Anhui Miisen Intelligence Technology Co., Ltd.20240—