510(k) Report

Devices descending from K213562

9 later devices reach DTX Studio Clinic 3.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233925Relu CreatorRelu BV20246—
+1K231898DTX Studio Clinic (4.0)Nobel Biocare AB20231—
+2K260785DS Core CBCT AnatomyDentsply Sirona20261—
+2K252538CEPHX3DOrca Dental AI, Ltd.20260—
+2K251514Overjet CBCT AssistOverjet, Inc.20250—
+2K252086DTX Studio AssistNobel Biocare C/O Medicim NV20250—
+2K243989Second Opinion® 3DPearl, Inc.20253—
+3K262127DS Core CBCT AnatomyDentsply Sirona20260—
+3K254096VELMENI for DENTISTS (V4D) 3DVelmeni, Inc.20260—