510(k) Report

Devices descending from K160425

26 later devices reach CAD/CAMouflage Milling Bock through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162537CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc.201625—
+2K201668VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG202024—
+3K233273C&B Ceramic; C&B Permanent; C&B InterimPrevest Denpro Limited20240—
+3K211345C-30 Crown KitPerfect Fit Crowns, LLC20210—
+3K202846Tera HarzGraphy, Inc.202113—
+3K210977E-Dent 1000Envisiontec GmbH20217—
+4K241673Denture Base Resin (PN-Denture (Red, White))Shenzhen Piocreat 3D Technology Co., Ltd.20240—
+4K232559C&B NFH HybridArum Dentistry Co., Ltd.20240—
+4K231142Temporis, Irix PlusDws S.R.L.20240—
+4K233502Tera Harz IIGraphy, Inc.20231—
+4K222623Digital CrownSprintray, Inc.20224—
+4K222877FREEPRINT crownDetax GmbH20222—
+4K220771Stratasys TrueDentStratasys, Ltd.202215
+4K213343Saremco Print CROWNTECSaremco Dental AG20226—
+5K260152Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.20260—
+5K260661Midas RestoreSprintray, Inc.20260—
+5K260170LumiCeraHangzhou SHINING3D Dental Technology Co., Ltd.20260—
+5K250763ReonC.E.I.B.Med20250—
+5K250497Additive Manufacturing (Light Curing) Crown Bridge ResinAidite (Qinhuangdao) Technology Co., Ltd.20250—
+5K242277Crown HTSprintray, Inc.20241—
+5K241071NextDent Jet Denture Base; NextDent Jet Denture TeethVertex-Dental B.V.20240—
+5K232050saremco print BRIDGETECSaremco Dental AG20230—
+5K233596VarseoSmile TriniQBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG20233—
+6K261246SRGC-06GC America, Inc.20260—
+6K253053Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)Hangzhou SHINING3D Dental Technology Co., Ltd.20251—
+7K261356Dura-CrownHangzhou SHINING3D Dental Technology Co., Ltd.20260—