510(k) Report

Devices descending from K053060

21 later devices reach TCS Unbreakable through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242897Partial FlexClemde SA DE CV20250—
+1K250617Apex FlexSprintray, Inc.20253—
+1K170375Nobilplast Denture ResinCmp Industries, LLC20170—
+1K152270Denture base resinKorea Engineering Plastics Co., Ltd.20150—
+1K142894TCS BlendThermoplastic Comfort Systems, Inc.20150—
+1K123220Vertex Thermosens RigidVertex-Dental B.V.201310—
+1K113608DeflexNuxen S.R.L.20121—
+1K113788Deflex AcrilatoNuxen S.R.L.20120—
+2K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.20260—
+2K261474DENTCA Tru FlexibleDentca, Inc.20260—
+2K253365LuxCreo Flexible Partial Denture ResinLuxCreo, Inc.20250—
+2K190790Flex FitDk Mungyo Corporation20200—
+2K132725Juvora Dentqal DiscJuvora20148—
+3K160918JUVORA Dental Disc, Ceramill PEEK by JUVORAJuvora20173—
+3K152113BioHPP - breCAM.BioHPPBredent GmbH & Co. KG20163—
+4K233171PF Keep; Cad Cam Keep BlockClemde SA DE CV20230—
+4K220329G-CAMGraphenano Dental S.L.202211
+4K181484Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral TissueZirkonzahn Srl20180—
+4K173124PEEK BiosolutionMerz Dental GmbH20170—
+4K170102Pekkton IvoryCendres+Metaux SA20170—
+5K253236G-BlockGraphenano Dental S.L.20250—