510(k) Report

Devices descending from K210977

7 later devices reach E-Dent 1000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241673Denture Base Resin (PN-Denture (Red, White))Shenzhen Piocreat 3D Technology Co., Ltd.20240—
+1K222623Digital CrownSprintray, Inc.20224—
+1K220771Stratasys TrueDentStratasys, Ltd.202215
+2K260152Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.20260—
+2K260661Midas RestoreSprintray, Inc.20260—
+2K242277Crown HTSprintray, Inc.20241—
+3K261246SRGC-06GC America, Inc.20260—