510(k) Report

Devices descending from K201668

24 later devices reach VarseoSmile Crown plus through their predicates, nearest generation first.

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