510(k) Report

Devices descending from K053438

19 later devices reach Glass Ceramics through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111573Monobloc BM SeriesHass Corp.20110—
+1K091826Elegant3M Espe AG Dental Products20090—
+1K090718Bellus Shading Kit3M Espe AG Dental Products20091—
+1K070537ZirblockCdl Technologies, Inc.20071—
+1K063511Ceramill ZIAmann Girrbach America, Inc.200712—
+2K173971K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucentYeti Dentalprodukte GmbH20180—
+2K171876Ceramill Zolid HT+ whiteAmann Girrbach AG20171—
+2K152383Ceramill Zolid FXEmergo Europe Consulting20153—
+2K130604Universal Paste Stains and GlazePrismatik Dentalcraft, Inc.20130—
+2K100250XceramXceramusa20100—
+2K092513Rainbow BlockGenoss Co., Ltd.20095—
+3K260918Zolid LunarisAmann Girrbach AG20260—
+3K170050Z-CAD smileMetoxit AG20181—
+3K151842Rainbow ShineGenoss20162—
+3K151723Rainbow TransGenoss20150—
+3K151844Rainbow ShadeGenoss20150—
+4K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+4K160079rainbow ShineGenoss Co., Ltd.20161—
+5K232174rainbowTM Multi-Layer Block / bright 3-Layer / bright MonoGenoss Co., Ltd.20240—