510(k) Report

Devices descending from K011394

40 later devices reach Lava Frame, Lava Frame Shade, Lava Ceram through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161922XP2023M Deutschland GmbH20161—
+1K132102Bece Cad Zirkon HT+Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO20131—
+1K120011Heisenberg Effect Shades3M Espe AG20122—
+1K112806Jensen ZirconiaJensen Industries, Inc.20110—
+1K112710Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR, Zenostar Color ZRWieland Dental + Technik GmbH & Co. KG201116—
+1K111257Heisenberg Dyeing Liquids3M Espe AG20116—
+1K100232Luminesse ZR BlanksTalladium, Inc.201001
+1K092630ZIROXZencera, Inc.20091—
+1K092020Aadva ZR Coloring LiquidGC America, Inc.20091—
+1K091826Elegant3M Espe AG Dental Products20090—
+1K090718Bellus Shading Kit3M Espe AG Dental Products20091—
+1K083201Zmatch BlockDentaim Co., Ltd.20091—
+1K073314Heany Industries Inc Dental XirconiaHeany Industries, Inc.20081—
+1K063842Cyrtina SystemOratio B.V.20070—
+1K042548Cerasys - ZRCerasys, Inc.20040—
+2K233158Copra Smile, Copra Supreme HyperionWhitepeaks Dental Solutions GmbH20240—
+2K212548LUXEN CL Dental LiquidDentalmax Co., Ltd.20210—
+2K182833ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic ReducerThe Argen Corporation20195—
+2K143071Nacera PearlDoceram Medical Ceramics GmbH20150—
+2K140491Tanaka Zircolor Coloring Liquid, Tanaka Zircolor Dipping Liquid and Tanaka Enamel ZR…Tanaka Dental20150—
+2K150056Luxisse+Heany Industries, Inc.20150—
+2K142233zenostar MO, Zenostar T, Zenostar VisualiZrWieland Dental + Technik GmbH & Co. KG201511
+2K140070Luxer Shaded ZirconiaContinental Dental Ceramics, Inc.20144—
+2K133213StarceramH.C. Starck Ceramics GmbH20133—
+2K130604Universal Paste Stains and GlazePrismatik Dentalcraft, Inc.20130—
+2K130184ZenoluxWieland Dental + Technik GmbH & Co. KG20130—
+2K100250XceramXceramusa20100—
+2K093571ZR Dental BlockAms Co., Ltd.20100—
+3K253953IPS e.max ZirconiaIvoclar Vivadent, Inc.20260—
+3K230262BruxZir™ Incisal Coloring LiquidPrismatik Dentalcraft, Inc.20230—
+3K190518Color Liquid, Vita LiquidZirkonzahn Srl20193—
+3K172761New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)Shanghai New Century Dental Materials Co., Ltd.20172—
+3K161025priti multidisc ZrO2 High TranslucentPritidenta GmbH20170—
+3K143656StarCeram® Z-Nature, StarCeram® Z-SmileH.C. Starck Ceramics GmbH20150—
+3K140924StarceramH.C. Starck Ceramics GmbH20141—
+4K220369Esthetic ColorantKuraray Noritake Dental, Inc.20220—
+4K220960BruxZir Opaque Coloring LiquidPrismatik Dentalcraft, Inc.20221—
+4K192535Unshaded Dental Zirconia and Pre-Shaded Dental ZirconiaQinhuangdao Audental Metal Technology Co., Ltd.20200—
+4K181816Ceramic Denture Zirconia Ceramics BlockQinhuangdao Silide Ceramic Technology Co., Ltd.20180—
+5K231347BruxZir™ TintEFX Coloring LiquidPrismatik Dentalcraft, Inc.20230—