510(k) Report

Devices descending from K982201

11 later devices reach Zenith Luxacore Automix Core Material (Multiple) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K014111Rebilda SCVoco GmbH20020—
+1K012307Luxacore/Luxacore DualDmg USA, Inc.20019—
+2K260805Dual CoreVericom Co., Ltd.20260—
+2K252465Any-CoreMediclus Co., Ltd.20250—
+2K143104Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-XKettenbach GmbH & Co. KG20151—
+2K121769Dentocore / Dentocore BodyItena Clinical20130—
+2K092572Core*IT DualSpident Co., Ltd.20091—
+2K041960Composite/Compomer Repair KitDmg USA, Inc.20041—
+3K262982Core·it DualSpident Co., Ltd.20260—
+3K191527Visalys CemCore, Visalys Cem Core Try In PasteKettenbach GmbH & Co. KG20190—
+3K063444Total Etch Bonding AgentDmg USA, Inc.20070—