510(k) Report

Devices descending from K051705

228 later devices reach Ips E.Max Cad/Ips E.Max Zircad through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260859Rosetta SM, Rosetta SPHass Corp.20260—
+1K232952Copran ZriWhitepeaks Dental Solutions GmbH20240—
+1K230487Dental Lithium Disilicate Glass-CeramicFuzhou Rick Brown Biomaterials Co., Ltd.20232—
+1K211308Inni-CeraAon Co., Ltd.20211—
+1K211916IPS e.max OneIvoclar Vivadent, AG20210—
+1K203672MAZIC Claro CAD and MAZIC Claro PressVericom Co., Ltd.20210—
+1K160262n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,Institut Straumann AG20164—
+1K153130Initial LiSi BlockGC America, Inc.20160—
+1K160144rainbow LS BlockGenoss Co., Ltd.20160—
+1K152118Zenostar MT, Zenostar Color LiquidsWieland Dental + Technik GmbH & Co. KG2015021
+1K142233zenostar MO, Zenostar T, Zenostar VisualiZrWieland Dental + Technik GmbH & Co. KG201511
+1K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+1K123615Iris - High Strength Glass CeramicDentsply Intl.20130—
+1K100794Fluorcanasite Dental CeramicDr Sarah Pollington20110—
+1K100512Nobelprocera Ips E.Max CrownNobel Biocare AB20101—
+1K100781Obsidian Ceramic BlocksPrismatik Dentalcraft, Inc.20105—
+1K100232Luminesse ZR BlanksTalladium, Inc.201001
+1K081749Avante Z Zirconia (as)3 BlocksPentron Ceramics, Inc.20081—
+1K073314Heany Industries Inc Dental XirconiaHeany Industries, Inc.20081—
+1K072569Metoxit Cam-BlanksMetoxit AG2007186—
+1K062389Z-Block, Models 20/19, 40/19, 55/19Foundation Milling Centre20060—
+2K253953IPS e.max ZirconiaIvoclar Vivadent, Inc.20260—
+2K252789Glass CeramicShenzhen Xiangtong Co., Ltd.20250—
+2K242740Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)Liaoning Rachcera Material Technology Co., Ltd.20240—
+2K240419UltraThineer Zirconia Slurry (5Y-B)Boston Micro Fabrication20240—
+2K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+2K202952Amber Mill Q Series & Amber Mill Direct SeriesHass Corp.20211—
+2K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+2K173971K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucentYeti Dentalprodukte GmbH20180—
+2K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+2K173410n!ce for PlanmillInstitut Straumann AG20170—
+2K170420n!ce Glass Ceramic Blocks for Amann GirrbachInstitut Straumann AG20170—
+2K162677L- OVCRhondium, Ltd.20160—
+2K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+2K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+2K150056Luxisse+Heany Industries, Inc.20150—
+2K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+2K141887Obsidian Press (All Ceramic and Pom)Prismatik Dentalcraft, Inc.20142—
+2K141788Obsidian Milling BlocksPrismatik Dentalcraft, Inc.20142—
+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—
+2K082137DLMS-ZirblocksDental Milling Laboratory Supplies (Dlms)20090—
+2K081263StarceramH.C. Starck Ceramics GmbH & Co.Kg200817—
+3K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.20260—
+3K234014Obsidian® NOWPrismatik Dentalcraft, Inc.20240—
+3K233016Dental Glass CeramicsShenzhen Yurucheng Dental Materials Co., Ltd.20230—
+3K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+3K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+3K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+3K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+3K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+3K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+3K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+3K160102Amber Mill Series and Amber Press SeriesHass Corp.20160—
+3K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+3K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+3K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+3K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+3K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+3K150196DD cubeX2Dental Direkt GmbH20159—
+3K142987DD Bio Z, DD Bio ZX (square), DD BioZX (square) colorDental Direkt of Amerika UG (Haftungsbeschraenkt)20157—
+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—
+4K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+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—
+4K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+4K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+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—
+4K192742Straumann Variobase CInstitut Straumann AG20211—
+4K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+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—
+4K171532TruBase STruabutment, Inc.20187—
+4K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+4K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+4K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+4K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+4K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+4K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+4K163238Eclipse Kiss ZirconiaAms20170—
+4K162390ET Hybrid AbutmentHiossen, Inc.20172—
+4K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+4K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+4K160203Adamant Zirconia DiscAdamant Co., Ltd.20160—
+4K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+4K160784CAM Titanium BlanksAltatec GmbH20161—
+4K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+4K143656StarCeram® Z-Nature, StarCeram® Z-SmileH.C. Starck Ceramics GmbH20150—
+4K143071Nacera PearlDoceram Medical Ceramics GmbH20150—