510(k) Report

Devices descending from K140445

15 later devices reach Dexis Software: Dexis Imaging Suite, Dexis Mac through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162799CliniviewPalodex Group OY201713—
+1K151941DEXIS WebviewImaging Sciences International /Gendex/Dexis20150—
+2K203156DTX Studio ClinicNobel Biocare AB202010—
+2K192165Acteon Imaging SuiteDe Gotzen S.R.L.20200—
+2K172224DTX Studio diagnoseNobel Biocare AB20180—
+3K213562DTX Studio Clinic 3.0Nobel Biocare AB20229—
+4K233925Relu CreatorRelu BV20246—
+4K231898DTX Studio Clinic (4.0)Nobel Biocare AB20231—
+5K260785DS Core CBCT AnatomyDentsply Sirona20261—
+5K252538CEPHX3DOrca Dental AI, Ltd.20260—
+5K251514Overjet CBCT AssistOverjet, Inc.20250—
+5K252086DTX Studio AssistNobel Biocare C/O Medicim NV20250—
+5K243989Second Opinion® 3DPearl, Inc.20253—
+6K262127DS Core CBCT AnatomyDentsply Sirona20260—
+6K254096VELMENI for DENTISTS (V4D) 3DVelmeni, Inc.20260—